SIST EN ISO 21647:2005
(Main)Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende Sicherheit und grundlegenden Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 21647:2004)
Diese Norm legt besondere Anforderungen für die grundlegende Sicherheit und grundlegende Leistungsmerkmale von ÜBERWACHUNGSGERÄTEN FÜR ATEMGASE (respiratory gas monitor, RGM) (wie in 3.17 definiert) fest, die für die ununterbrochene Anwendung am Menschen bestimmt sind.
Gegenwärtig legt diese Norm Anforderungen fest für:
aa) Überwachungsgeräte für Anästhesiegase;
bb) Überwachungsgeräte für Kohlendioxid;
cc) Überwachungsgeräte für Sauerstoff.
Überwachungsgeräte, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, liegen außerhalb des Anwendungsbereichs dieser Norm.
Appareils électromédicaux - Prescriptions particulieres relatives a la sécurité et aux performances de base des moniteurs de gaz respiratoires (ISO 21647:2004)
Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov (ISO 21647:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21647:2005
01-marec-2005
1DGRPHãþD
SIST EN 12598:2000
SIST EN 864:2000
SIST EN ISO 11196:2000
Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene
lastnosti monitorjev dihalnih plinov (ISO 21647:2004)
Medical electrical equipment - Particular requirements for the basic safety and essential
performance of respiratory gas monitors (ISO 21647:2004)
Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende
Sicherheit und grundlegenden Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 21647:2004)
Appareils électromédicaux - Prescriptions particulieres relatives a la sécurité et aux
performances de base des moniteurs de gaz respiratoires (ISO 21647:2004)
Ta slovenski standard je istoveten z: EN ISO 21647:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 21647:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 21647:2005
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SIST EN ISO 21647:2005
EUROPEAN STANDARD
EN ISO 21647
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2004
ICS 11.040.10 Supersedes EN 12598:1999, EN 865:1997,
EN ISO 11196:1997
English version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of respiratory gas
monitors (ISO 21647:2004)
Appareils électromédicaux - Prescriptions particulières Medizinische elektrische Geräte - Besondere Festlegungen
relatives à la sécurité et aux performances de base des für die grundlegende Sicherheit und grundlegenden
moniteurs de gaz respiratoires (ISO 21647:2004) Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 21647:2004)
This European Standard was approved by CEN on 8 August 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21647:2004: E
worldwide for CEN national Members.
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SIST EN ISO 21647:2005
EN ISO 21647:2004 (E)
Foreword
This document (EN ISO 21647:2004) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
"Respiratory and anaesthetic equipment", the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2005, and conflicting national standards shall
be withdrawn at the latest by May 2005.
This document supersedes EN 12598:1999, EN 865:1997 and EN ISO 11196:1997.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 21647:2004 has been approved by CEN as EN ISO 21647:2004 without any
modifications.
2
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SIST EN ISO 21647:2005
EN ISO 21647:2004 (E)
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC.
Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding Essential Requirements of that
Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause/Subclause of Corresponding Essential Principal Comments
this Standard
6.1 d) 13.2, 13.3 a)
6.1 aa) to 6.1 hh) 13.2
6.1 dd) 13.3 f)
6.1 ee) 13.3 k)
6.1 ff) 13.3 e)
6.8.2 aa) 13.4
6.8.2 cc) 1) 6.8.2 hh), 13.6 b)
6.8.2 cc) 2) 13.6 a), 13.6 b)
6.8.2 cc) 3) 13.6 a), 13.6 d), 13.6 i)
6.8.2 cc) 3) iv) 13.6 a), 13.6 h)
6.8.2 dd) 13.6 a), 13.6 c)
6.8.2 ee) 13.6 c)
6.8.2 ff) to 6.8.2 hh) 13.6 a)
Table BB.1 also applies.
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SIST EN ISO 21647:2005
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SIST EN ISO 21647:2005
INTERNATIONAL ISO
STANDARD 21647
First edition
2004-11-15
Medical electrical equipment — Particular
requirements for the basic safety and
essential performance of respiratory gas
monitors
Appareils électromédicaux — Prescriptions particulières relatives à la
sécurité et aux performances de base des moniteurs de gaz
respiratoires
Reference number
ISO 21647:2004(E)
©
ISO 2004
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SIST EN ISO 21647:2005
ISO 21647:2004(E)
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ii © ISO 2004 – All rights reserved
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SIST EN ISO 21647:2005
ISO 21647:2004(E)
Contents Page
Foreword. vi
Introduction . vii
1* Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 4
4.101 Other test methods . 4
4.102 Acceptance criteria . 4
5 Classification. 5
6 Identification, marking and documents. 5
6.1 Marking on the outside of equipment or equipment parts . 5
6.3 Markings of controls and instruments. 5
6.8.2* Instructions for use. 6
6.101* Test for legibility . 8
7 Power input. 8
8 Basic safety categories . 8
9 Removable protective means . 8
10 Environmental conditions. 8
10.1 Transport and storage . 8
10.2.2 Power supply. 8
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 9
16 Enclosures and protective covers . 9
17 Separation. 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous leakage currents and patient auxiliary currents . 9
20 Dielectric strength. 9
21* Mechanical strength . 9
21.101 Shock and vibration. 10
21.102 Shock and vibration for transport . 10
22 Moving parts. 11
23 Surfaces, corners and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
26 Vibration and noise. 12
© ISO 2004 – All rights reserved iii
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SIST EN ISO 21647:2005
ISO 21647:2004(E)
27 Pneumatic and hydraulic power .12
28 Suspended masses.12
29 X-Radiation.12
30 Alpha, beta, gamma, neutron radiation and other particle radiation.12
31 Microwave radiation.12
32 Light radiation (including lasers).12
33 Infra-red radiation.12
34 Ultraviolet radiation.12
35 Acoustical energy (including ultrasonics).12
36* Electromagnetic compatibility .12
37 Locations and basic requirements.13
38 Marking and accompanying documents.13
39 Common requirements for category AP and category APG equipment .13
40 Requirements and tests for category AP equipment, parts and components thereof .13
41 Requirements and tests for category APG equipment, parts and components thereof .13
42 Excessive temperatures .13
43* Fire prevention.13
43.101 RGM used in conjunction with oxidants.13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.14
44.3 Spillage.14
44.7 Cleaning, sterilization and disinfection .14
44.8 Compatibility with substances used with the equipment .14
45 Pressure vessels and parts subject to pressure .15
46 Human errors .15
47 Electrostatic charges .15
48 Biocompatibility.15
49 Interruption of the power supply .15
49.101 Power failure alarm conditions.15
49.102 Settings and data storage following short interruptions or automatic switchover .15
49.103 Reserve electrical power source .16
49.104 Reserve electrical power source for use outside the healthcare facility .16
50 Accuracy of operating data .16
51 Protection against hazardous output.16
51.101* Measurement accuracy.16
51.102 Total system response time .19
51.103 Indication of gas readings units of measure.20
51.104 Indication of operating mode.20
52 Abnormal operation and fault conditions.20
53 Environmental tests .20
54 General .20
55 Enclosures and covers .20
56 Components and general assembly.20
56.7 Batteries .20
iv © ISO 2004 – All rights reserved
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SIST EN ISO 21647:2005
ISO 21647:2004(E)
57 Mains parts, components and layout. 20
57.3 Power supply cords . 21
58 Protective earthing — terminals and connections . 21
59 Construction and layout. 21
101 Additional requirements specifically related to respiratory gas monitors . 21
101.1 Interfering gas and vapour effects . 21
101.2 Gas leakage . 22
101.3* Exhaust port connector for diverting respiratory gas monitor. 22
101.4 Minimum sampling flowrate. 22
101.5 Contamination of breathing systems. 23
102 Alarm systems. 23
201.1.2* Alarm condition priority. 23
201.2 Disclosures for intelligent alarm system. 25
201.5 Alarm presets . 25
201.5.1 General requirements . 25
201.6.2 Adjustable alarm limit. 25
201.8 Alarm signal inactivation states . 25
201.8.3 Indication and access. 25
103 Appendices of IEC 60601-1:1988. 25
Annex A A (informative) Rationale. 26
Annex B B (informative) Reference to the Essential Principles . 33
Annex C C (informative) Environmental aspects . 36
Annex D D (informative) Vocabulary — Index of defined terms . 38
Bibliography . 40
© ISO 2004 – All rights reserved v
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SIST EN ISO 21647:2005
ISO 21647:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 21647 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This first edition of ISO 21647 cancels and replaces ISO 7767:1997, ISO 9918:1993 and ISO 11196:1995,
which have been technically revised.
vi © ISO 2004 – All rights reserved
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SIST EN ISO 21647:2005
ISO 21647:2004(E)
Introduction
This International Standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1
(1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic
standard for the safety of all medical electrical equipment used by or under the supervision of qualified
personnel in the general medical and patient environment; it also contains certain requirements for reliable
operation to ensure safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The
Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency
surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this International Standard, the following drafting conventions have been applied.
The changes to the text of IEC 60601-1:1988, the General Standard, as supplemented by the Collateral
Standards, are specified by the use of the following words.
“Replacement” means that the indicated clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
“Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list
element, note, table, figure) additional to the General Standard.
“Amendment” means that existing text of the General Standard is partially modified by deletion and/or
addition as indicated by the text of this Particular Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: clauses, subclauses, tables and figures are
numbered starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered
AA, BB, etc.
In this International Standard, the following print types are used:
requirements, compliance with which can be tested, and definitions: roman type;
notes and examples: smaller roman type;
description of type of document change, and test specifications: italic type;
terms defined in Clause 2 of the General Standard IEC 60601-1:1988 or in this Particular Standard: bold.
Throughout this Particular Standard, text for which a rationale is provided in Annex AA, is indicated by an
asterisk (*).
© ISO 2004 – All rights reserved vii
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SIST EN ISO 21647:2005
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SIST EN ISO 21647:2005
INTERNATIONAL STANDARD ISO 21647:2004(E)
Medical electrical equipment — Particular requirements for the
basic safety and essential performance of respiratory gas
monitors
1* Scope
IEC 60601-1:1998, Clause 1, applies, except as follows.
Amendment (add at the end of 1.1):
This International Standard specifies particular requirements for the basic safety and essential performance of
respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans.
This International Standard specifies requirements for
aa) anaesthetic gas monitoring,
bb) carbon dioxide monitoring,
cc) oxygen monitoring.
This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) a
...
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