iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty!
ISO

ISO/FDIS 10079-4

(Main)

Medical suction equipment

Medical suction equipment

Appareils d’aspiration médicale

General Information

Status
Published
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
ISO/TC 121/SC 8 - Suction devices
Drafting Committee
ISO/TC 121/SC 8 - Suction devices
Current Stage
5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
Start Date
30-Apr-2021
Completion Date
30-Apr-2021
Ref Project

Buy Standard

ISO/FDIS 10079-4 - Medical suction equipmentISO/FDIS 10079-4 - Medical suction equipment
PreviousNext
Draft
ISO/FDIS 10079-4 - Medical suction equipment
English language
35 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10079-4
ISO/TC 121/SC 8
Medical suction equipment —
Secretariat: SA
Voting begins on:
Part 4:
2021-04-30
General requirements
Voting terminates on:
2021-06-25
Appareils d’aspiration médicale —
Partie 4: Exigences générales
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 10079-4:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 10079-4:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 10079-4:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 General requirements ..................................................................................................................................................................................... 4

4.1 Risk management ................................................................................................................................................................................. 4

4.2 Usability ........................................................................................................................................................................................................ 5

4.3 Clinical studies ........................................................................................................................................................................................ 5

4.4 Biophysical or modelling research ........................................................................................................................................ 5

4.5 Test methods ............................................................................................................................................................................................. 5

5 Materials ....................................................................................................................................................................................................................... 5

5.1 Natural rubber latex ........................................................................................................................................................................... 5

5.2 Cleaning disinfection and sterilization ............................................................................................................................... 6

6 Design requirements ........................................................................................................................................................................................ 6

6.1 General ........................................................................................................................................................................................................... 6

6.2 Collection containers ....................................................................................................................................................................... 6

6.2.1 Capacity (See also Annex A Subclause 6.2.1 for rationale).......................................................... 6

6.2.2 Strength ................................................................................................................................................................................... 7

6.3 Connections ............................................................................................................................................................................................... 7

6.3.1 Tubing connectors .......................................................................................................................................................... 7

6.3.2 Collection container inlet ports ....................................................................................................................... 7

6.3.3 Collection container exhaust ports .............................................................................................................. 7

6.4 Suction tubing and intermediate tubing (See also Annex A Subclause 6.4 for rationale) 8

6.5 Vacuum level indicators .................................................................................................................................................................. 8

6.6 Environmental conditions for transport and storage ............................................................................................ 9

7 Performance requirements ....................................................................................................................................................................10

7.1 Operating position ............................................................................................................................................................................10

7.2 Protection devices .............................................................................................................................................................................10

7.2.1 Contamination protection .....................................................................................................................................10

7.2.2 Overfill protection devices ................................................................................................................................10

7.2.3 Pressure protection ....................................................................................................................................................10

7.3 Noise .............................................................................................................................................................................................................11

7.4 Air leakage ...............................................................................................................................................................................................11

7.5 Vacuum levels and free air flows .......................................................................................................................................11

7.6 Accuracy .....................................................................................................................................................................................................11

7.7 Pharyngeal suction equipment .............................................................................................................................................12

8 Additional/alternative requirements for suction equipment, suction tubing and

intermediate tubing designed for field use or transport use ................................................................................12

8.1 Physical requirements (See also Annex A, Subclause 8.1 for rationale) ............................................12

8.2 Strength ......................................................................................................................................................................................................12

8.3 Stability .......................................................................................................................................................................................................12

8.4 Environmental conditions during operation (See also Annex A, Subclause 8.4 for

rationale)...................................................................................................................................................................................................12

8.5 Collection container capacity ................................................................................................................................................13

9 Information supplied by the manufacturer ..........................................................................................................................13

9.1 General ........................................................................................................................................................................................................13

9.2 Symbols ......................................................................................................................................................................................................14

9.3 Marking ......................................................................................................................................................................................................14

9.4 Instructions for use ..........................................................................................................................................................................15

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 10079-4:2021(E)

Annex A (Informative) Rationale ...........................................................................................................................................................................17

Annex B (Normative) Test methods ...................................................................................................................................................................19

Annex C (informative) Schematic of medical suction equipment ........................................................................................34

Bibliography .............................................................................................................................................................................................................................35

iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 10079-4:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment subcommittee SC 8, Suction equipment, in collaboration with the European Committee for

Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in

accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

A list of all parts in the ISO 10079 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO/FDIS 10079-4:2021(E)
Introduction
[2]

Previously the ISO 10079 series of medical suction equipment standards comprised parts ISO 10079-1,

[3] [4]

ISO 10079-2 and ISO 10079-3 which had many common requirements. It was thought that

combining these common requirements into this new part 4 would prevent the inconsistencies that had

resulted from developing three different parts with common requirements and would make any future

revision/amendment easier to manage.

This document contains those requirements that are common to electrically, manually and gas-powered

medical suction equipment.
vi © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 10079-4:2021(E)
Medical suction equipment —
Part 4:
General requirements
1 Scope

This document specifies general requirements for medical suction equipment that are common to all

parts of the ISO 10079 series.
This document is not applicable to the following:

a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;

b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;

h) suction equipment where the collection container is downstream of the vacuum pump;

i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only
k) plume evacuation systems.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using

sound pressure — Engineering methods for an essentially free field over a reflecting plane

ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 7000, Graphical symbols for use on equipment — Registered symbols

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417, Medical devices — Information to be provided by the manufacturer
© ISO 2021 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO/FDIS 10079-4:2021(E)

ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors

for respiratory applications

ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors

for enteral applications

ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors

for neuraxial applications

ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications—Part 7 Connectors for

intravascular or hypodermic applications

I EC 6 06 01-1:20 05+A 1: 2012+ A 2: 2020, Medical electrical equipment — Part 1: General requirements for

safety
IEC 61672-1, Electroacoustics - Sound level meters — Part 1: Specifications

IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications—Part 5 Connectors

limb cuff inflation applications

EN 15986, Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices

containing phthalates
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
collection container
container in which liquids and solid particles are collected
3.2
collection container assembly
collection container and its closure with connectors for suction
3.3
drainage
removal of liquid, solid particles or gas from a body cavity or wound
3.4
end-piece

part of the suction equipment applied to the patient which begins at the site where material is drawn in

and ends at the first detachable connection
EXAMPLE Commonly used end-pieces include Yankauer sucker, suction catheters.
[1]
[Source: ISO 4135:2001, 8.2.7]
3.5
exhaust port
opening through which exhaust gas is discharged
3.6
field use

use of suction equipment in situations outside of a healthcare facility or home environment

2 © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
ISO/FDIS 10079-4:2021(E)
3.7
filter
device for retention of particulate matter
3.8
free air flow
rate of unrestricted flow of air through a designated inlet
3.9
high flow
free air flow ≥ 20 l/min
3.10
high vacuum
vacuum level of 60 kPa or stronger (absolute pressure 0 to 40 kPa)
3.11
inlet port
opening through which liquid, solid particles or gas enters
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum

suction in which the negative pressure applied to the end-piece is automatically and periodically

returned to atmospheric pressure
3.14
low flow
free air flow < 20 l/min
3.15
low vacuum
vacuum level of 20 kPa or weaker (absolute pressure 80 kPa to 100 kPa)
3.16
medium vacuum
vacuum level between 20 kPa and 60 kPa (absolute pressure 40 kPa to 80 kPa)
3.17
overfill protection device

device to prevent liquid or solid particles from entering the intermediate tubing

3.18
single fault condition

condition in which a single means for protection against a safety hazard in equipment is defective or a

single external abnormal condition is present

Note 1 to entry: Note to entry: Maintenance of equipment is considered a normal condition.

3.19
suction
application of vacuum to remove liquid, solid particles or gas
3.20
suction tubing

tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container

© ISO 2021 – All rights reserved 3
---------------------- Page: 9 ----------------------
ISO/FDIS 10079-4:2021(E)
3.21
thoracic drainage

drainage of liquid and gas from the thoracic cavity by application of suction to the thoracic cavity of the

patient
3.22
transport use
use during patient transport outside of a healthcare facility
EXAMPLE ambulance or aeroplane.
3.23
vacuum level
pressure less than atmospheric pressure
3.24
vacuum level indicator
device for displaying the vacuum level
3.25
vacuum regulator
device for controlling the applied vacuum level
3.26
vacuum source
component of device for generating vacuum
4 General requirements
4.1 Risk management

4.1.1 An established risk management process, (e.g. ISO 14971), shall be applied to the design of the

suction equipment. The risk management process shall include the following elements:

— risk analysis;
— risk evaluation; and
— risk control;
— production and post-production information.
Check conformance by inspection of the risk management file.

4.1.2 Suction equipment shall, when transported, stored, installed, operated in normal use and

maintained according to the instructions for use, present no risks that are not reduced to an acceptable

level using risk management procedures in accordance with ISO 14971 and which are associated with

their intended application in normal and in single fault condition.

NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/

hazardous situations might remain undetected over a period of time and as a consequence, might lead to an

unacceptable risk. In that case, a subsequent detected fault condition is considered a single fault condition. Specific

risk control measures to deal with such situations can be determined within the risk management process.

Check conformance by inspection of the risk management file.
4 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/FDIS 10079-4:2021(E)

4.1.3 Where requirements refer to freedom from unacceptable risk, the acceptability or unacceptability

of this risk shall be determined by the manufacturer in accordance with their policy for determining

acceptable risk.
Check conformance by inspection of the risk management file.
4.2 Usability

The manufacturer shall apply a usability engineering process to assess and mitigate any risks caused

[5]

by usability problems associated with correct use (i.e. normal use) and use errors (e.g. IEC 60601-1-6

[8]
and IEC 62366-1 ).
Check conformance by inspection of the usability engineering file.
4.3 Clinical studies

Where appropriate, clinical studies shall be performed under the conditions for which performance

is claimed and documented in the risk management file. The clinical studies shall comply with the

requirements of ISO 14155.
NOTE Clinical data can be sourced from the following:
— clinical investigation(s) of the device concerned;

— clinical investigation(s) or other studies reported in the scientific literature of a similar device for

which equivalence to the device in question can be demonstrated or

— published and/or unpublished reports on other clinical experience of either the device in question

or a similar device for which equivalence to the device in question can be demonstrated.

Check conformance by inspection of the risk management and technical files.
4.4 Biophysical or modelling research

Where appropriate, validated biophysical or modelling research shall be performed under the

conditions for which performance is claimed and documented in the risk management file.

NOTE Biophysical or modelling research is the application of validated physical methods and theories to

biological problems. Examples include the use of a combination of models, i.e. mathematical, computer, physical,

cell and tissue culture, and animal, in a complementary and interactive manner to simulate the performance of

medical devices.
Check conformance by inspection of the technical file.
4.5 Test methods

Manufacturers can use type tests different from those detailed within this document if an equivalent

degree of safety is obtained. Alternative test methods shall be validated against the test methods

specified in Annex B.
5 Materials
5.1 Natural rubber latex

If any components of the suction equipment incorporate natural rubber latex, the manufacturer

shall provide a specific justification for using this substance in their technical file. See also 9.3 g) for

additional marking requirements.
Check conformance by inspection of the technical file.
© ISO 2021 – All rights reserved 5
---------------------- Page: 11 ----------------------
ISO/FDIS 10079-4:2021(E)
5.2 Cleaning disinfection and sterilization

5.2.1 Parts of the suction equipment which can be subject to contamination shall either be for single

use or capable of being cleaned and disinfected or sterilized as appropriate.
Check conformance by inspection of the technical file.

5.2.2 Parts of the suction equipment intended for re-use shall meet the requirements of Clause 7, as

appropriate, after those components have been subjected to 30 cycles of cleaning and disinfection or

sterilization as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in Annex B.
6 Design requirements
6.1 General

6.1.1 Suction equipment classified as medical electrical equipment, as defined in IEC 60601-1:2005+A1:

2012 +A2:2020: 3 .63 shall meet the relevant requirements of IEC 60601-1.

NOTE This applies not only to electrically powered suction equipment but also to suction equipment with

electrical components e.g. timers, indicators etc.
Check conformance by inspection of the technical file.

6.1.2 Suction equipment intended to be dismantled by the user (e.g. for cleaning) shall be designed to

facilitate correct assembly or marked to indicate correct reassembly.
Check conformance by inspection of the technical file.

6.1.3 Suction equipment shall meet the requirements of Clause 7, as appropriate, after dismantling and

reassembly in accordance with the manufacturer’s instructions.

Check conformance by the tests given in Annex B after the suction equipment has been reassembled.

6.1.4 Suction equipment shall be designed to be operated by one person, unaided.
Check conformance by functional testing.

6.1.5 Means shall be provided to prevent foam passing from the collection container into the vacuum

source.

NOTE This does not apply to suction equipment designed to continue to operate when the collection container

is full. [See 8.5 b)].
Check conformance by the tests given in B.2.3.
6.2 Collection containers
6.2.1 Capacity (See also Annex A Subclause 6.2.1 for rationale)
Collection containers shall:
a) clearly show the level of contents, and
b) have a usable volume ≥500 ml.
6 © ISO 2021 – All rights reserved
---------------------- Page: 12 ----------------------
ISO/FDIS 10079-4:2021(E)

NOTE 1 Transparent or translucent collection containers allow a qualitative assessment of the contents.

NOTE 2 See Clause 8 for additional/alternative requirements for the capacity of collection containers for

suction equipment for field use.
Check conformance by the tests given in B.2.
6.2.2 Strength

Collection containers shall not implode, crack or permanently deform and shall meet the requirements

of Clause 7, as appropriate, after being subjected to a pressure of either 120 % of the manufacturer’s

recommended maximum vacuum level or 95 kPa below atmospheric, whichever is the stronger vacuum

level, for 5 min.

Reusable collection containers shall be tested after 30 cycles of cleaning and disinfection or sterilization

as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in B.3.
6.3 Connections
6.3.1 Tubing connectors
Connectors for suction tubing and intermediate tubing shall:

a) be designed to facilitate correct assembly or clearly marked to indicate correct assembly when all

parts are mated and

b) have an inside diameter equal to or larger than the inside diameter of the largest suction tubing or

intermediate tubing size specified by the manufacturer [see 9.4 n)].

NOTE Incorrect connections have frequently been a cause of spill over into the vacuum source and a loss of

suction.
Check conformance by functional testing and inspection.
6.3.2 Collection container inlet ports
Collection container inlet ports shall:

a) not be compatible with any of the conical connectors specified in ISO 5356-1 or any of the small-

bore connectors specified in ISO 80369-2, ISO 80369-3, ISO 80369-4, ISO 80369-5, ISO 80369-6,

ISO 80369-7 and
b) have an inside diameter ≥6 mm.
Check conformance by functional testing.
6.3.3 Collection container exhaust ports

It shall not be possible to connect suction tubing or intermediate tubing to collection container exhaust

ports.
Check conformance by functional testing.
© ISO 2021 – All rights reserved 7
---------------------- Page: 13 ----------
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ISO
ISO 10079-1:2015/Amd 1:2018(Amendment)
Changes to requirements for operating at extremes of temperature
  • Standard
    1 page
    English language
    sale 15% off
  • Standard
    1 page
    French language
    sale 15% off
ISO
ISO 10079-1:2015(Main)
Medical suction equipment

ISO 10079-1:2015 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use. ISO 10079-1:2015 does not apply to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) mucus extractors including neonatal mucus extractors; i) suction equipment where the collection container is downstream of the vacuum pump; j) ventouse (obstetric) equipment; k) suction equipment marked for endoscopic use only; l) plume evacuation systems.

  • Standard
    30 pages
    English language
    sale 15% off
  • Standard
    30 pages
    English language
    sale 15% off
  • Standard
    30 pages
    French language
    sale 15% off
  • Standard
    30 pages
    French language
    sale 15% off
ISO
ISO 10079-2:2014(Main)
Medical suction equipment

ISO 10079-2:2014 specifies safety and performance requirements for medical, manually powered suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both. Annex C illustrates the three parts of ISO 10079 by providing a schematic for typical systems. ISO 10079-2:2014 has additional requirements for suction equipment intended for field use or transport use.

  • Standard
    19 pages
    English language
    sale 15% off
  • Standard
    20 pages
    French language
    sale 15% off
ISO
ISO 10079-3:2014(Main)
Medical suction equipment

ISO 10079-3:2014 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. The equipment can be stand-alone or part of an integrated system.

  • Standard
    30 pages
    English language
    sale 15% off
  • Standard
    32 pages
    French language
    sale 15% off
ISO
ISO 407:2021(Main)
Small medical gas cylinders -- Pin-index yoke-type valve connections

This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both. NOTE 1   This type of connection is primarily used for small cylinders (5 l or below). NOTE 2   In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2). This document specifies: —   basic dimensions; —   requirements for alternative designs of the yoke-type valve connections; —   dimensions and positions for the holes and pins for the outlet connections. It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.

  • Standard
    20 pages
    English language
    sale 15% off
  • Standard
    20 pages
    French language
    sale 15% off
  • Draft
    20 pages
    English language
    sale 15% off
  • Draft
    20 pages
    French language
    sale 15% off
ISO
ISO 80601-2-87:2021(Main)
Medical electrical equipment

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1   For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining. NOTE 2   For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator). NOTE 3   A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment. intended to be operated by a healthcare professional operator; intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and capable of providing more than 150 inflations/min. There are three principal designations of HFV: high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min]; high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase]. Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min. * A high-frequency ventilator is not considered a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005. NOTE 4   Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: non-high-frequency ventilators or accessories which provide conventional ventilation for use in critical care environments, which are given in ISO 80601-2-12 [23];. NOTE 5    An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO 80601-2-12 is applicable to those modes. ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 [24]; ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84, the replacement for ISO 10651-3 [13]; NOTE 6    An HFV can incorporate EMS ventilator capability. ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72 [26]; ventilators or accessories intended for

  • Standard
    136 pages
    English language
    sale 15% off
  • Standard
    144 pages
    French language
    sale 15% off
  • Draft
    136 pages
    English language
    sale 15% off
  • Draft
    144 pages
    French language
    sale 15% off
ISO
ISO 80601-2-85:2021(Main)
Medical electrical equipment

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use. NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature. Not included within the scope of this document are: invasive tissue or vascular oximeters; oximeters that require a blood sample from the patient; equipment measuring dissolved oxygen; ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4]; ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61[3]; ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head. This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard. NOTE 2 See also 4.2 of the general standard. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability. This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment. NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

  • Standard
    107 pages
    English language
    sale 15% off
  • Standard
    108 pages
    English language
    sale 15% off
  • Standard
    128 pages
    French language
    sale 15% off
  • Standard
    126 pages
    French language
    sale 15% off
ISO
ISO 80601-2-70:2020(Main)
Medical electrical equipment

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].

  • Standard
    68 pages
    English language
    sale 15% off
  • Standard
    68 pages
    French language
    sale 15% off
  • Draft
    67 pages
    English language
    sale 15% off
  • Draft
    73 pages
    French language
    sale 15% off
ISO
ISO 80601-2-69:2020(Main)
Medical electrical equipment

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft. NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.

  • Draft
    62 pages
    English language
    sale 15% off
  • Draft
    68 pages
    French language
    sale 15% off
ISO
ISO 80601-2-67:2020(Main)
Medical electrical equipment

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

  • Standard
    57 pages
    English language
    sale 15% off
  • Standard
    61 pages
    French language
    sale 15% off
  • Draft
    57 pages
    English language
    sale 15% off
  • Draft
    63 pages
    French language
    sale 15% off