iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN ISO 11070:2015/A1:2018

(Amendment)

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung - Änderung 1 (ISO 11070:2014/Amd 1:2018)

Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables - Amendement 1 (ISO 11070:2014/Amd 1:2018)

Sterilni žilni instrumenti za enkratno uporabo - Dopolnilo A1 (ISO 11070:2014/Amd 1:2018)

General Information

Status
Published
Public Enquiry End Date
09-Feb-2018
Publication Date
23-Aug-2018
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
16-Jul-2018
Due Date
20-Sep-2018
Completion Date
24-Aug-2018
Ref Project
EN ISO 11070:2014/A1:2018 - Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Relations

Amends
SIST EN ISO 11070:2015 - Sterile, single-use intravascular catheter introducers (ISO 11070:2014)
Effective Date
01-Sep-2018

Buy Standard

EN ISO 11070:2015/A1:2018EN ISO 11070:2015/A1:2018
PreviousNext
Amendment
EN ISO 11070:2015/A1:2018
English language
8 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11070:2015/A1:2018
01-september-2018
Sterilni žilni instrumenti za enkratno uporabo - Dopolnilo A1 (ISO 11070:2014/Amd
1:2018)
Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO
11070:2014/Amd 1:2018)
Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen
Verwendung - Änderung 1 (ISO 11070:2014/Amd 1:2018)
Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables -
Amendement 1 (ISO 11070:2014/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 11070:2014/A1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11070:2015/A1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11070:2015/A1:2018

---------------------- Page: 2 ----------------------

SIST EN ISO 11070:2015/A1:2018


EN ISO 11070:2014/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2018
EUROPÄISCHE NORM
ICS 11.040.25
English Version

Sterile single-use intravascular introducers, dilators and
guidewires - Amendment 1 (ISO 11070:2014/Amd
1:2018)
Introducteurs, dilatateurs et guides intravasculaires Sterile Einführungsinstrumente, Dilatatoren und
stériles non réutilisables - Amendement 1 (ISO Führungsdrähte zur einmaligen Verwendung -
11070:2014/Amd 1:2018) Änderung 1 (ISO 11070:2014/Amd 1:2018)
This amendment A1 modifies the European Standard EN ISO 11070:2014; it was approved by CEN on 3 July 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This amendment 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 CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11070:2014/A1:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 11070:2015/A1:2018
EN ISO 11070:2014/A1:2018 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11070:2015/A1:2018
EN ISO 11070:2014/A1:2018 (E)
European foreword
This document (EN ISO 11070:2014/A1:2018) has been prepared by Technical Committee ISO/TC 84 "
Devices for administration of medicinal products and catheters " in collaboration with Technical
Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
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 January 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1617:1997.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11070:2014/Amd 1:2018 has been approved by CEN as EN ISO 11070:2014/A1:2018
without any modification.
3

---------------------- Page: 5 ----------------------

SIST EN ISO 11070:2015/A
...

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

SIST
SIST EN ISO 11608-5:2023(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
EN ISO 11608-5:2023

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

  • Standard
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 80369-3:2016/A1:2023(Amendment)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
EN ISO 80369-3:2016/A1:2022
  • Amendment
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11608-3:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
EN ISO 11608-3:2022

This document specifies requirements and test methods for design verification of containers and
integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container
closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated
with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also
scope of ISO 11608-1:2022).
This document is not applicable to the following products:
— sterile hypodermic needles;
— sterile hypodermic syringes;
— sterile single-use syringes, with or without needle, for insulin;
— containers that can be refilled multiple times;
— containers intended for dental use;
— catheters or infusion sets that are attached or assembled separately by the user

  • Standard
    35 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11608-2:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
EN ISO 11608-2:2022

This document specifies requirements and test methods for single-use, double-ended, sterile needles
intended to be used with some needle-based injection systems (NISs) that use a non-integrated doubleended needle according to ISO 11608-1.
This document is not applicable to the following:
— needles for dental use;
— pre-attached syringe needles;
— hypodermic needles;
— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
— materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain
requirements and tests methods that can be used to help design and evaluate them.
NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in
ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864.

  • Standard
    40 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    29 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11608-1:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
EN ISO 11608-1:2022

This document specifies requirements and test methods for Needle-Based Injection Systems (NISs)
for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can
be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular
delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone
prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
It is important to note that other functions and characteristics of the prefilled syringe, such as dose
accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document,
unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop
the plunger movement, which would limit the dose delivered). In that case, the system is completely
covered by this document and applicable requirements of the ISO 11608 series.
Excluded from the scope are:
— stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);
— NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal
product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy)
as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24,
ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);
— NISs with containers that can be refilled multiple times;
— requirements relating to methods or equipment associated with user filling of containers unless
they are dedicated accessories (a component necessary for primary function, whether included in
the original kitted product or not);
— NISs intended for dental use;
— NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
NOTE These products that are excluded might benefit from elements in this document but might not
completely fulfil the basic safety and effectiveness of such products.

  • Standard
    81 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    69 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11608-4:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
EN ISO 11608-4:2022

This document specifies requirements and test methods for needle-based injection systems (NISs)
containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be
operated with or without electrical/conductive connections to other devices. The system is intended to
deliver medication to a patient by self-administration or by administration by one other operator (e.g.
caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or
NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive
connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.

  • Standard
    72 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    56 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 26825:2022(Main)
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
EN ISO 26825:2022

This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name.
NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 80369-5:2017/AC:2022(Corrigendum)
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
EN 80369-5:2016/AC:2021-06

2021-06-25 - IEC Corrected version

  • Corrigendum
    3 pages
    English and French language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 80369-7:2021(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
EN ISO 80369-7:2021

This document specifies dimensions and requirements for the design and functional performance of
small-bore connectors intended to be used for connections in intravascular applications or hypodermic
connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip
connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these
connectors. Such requirements are given in particular documents for specific medical devices or
accessories.
This document does not specify requirements for the following small-bore connectors, which are
specified in other documents:
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and
applicable portion of ISO 8638 [6] referencing blood compartment ports);
— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
— infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into
medical devices or accessories, even if currently not required by the relevant particular medical device documents.
It is expected that when the relevant particular medical device documents are revised, requirements for smallbore
connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for
small-bore connectors intended for use with intravascular applications or hypodermic application medical devices
or accessories, which do not conform with this document.

  • Standard
    55 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    50 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 8836:2020(Main)
Suction catheters for use in the respiratory tract (ISO 8836:2019)
EN ISO 8836:2020

This document specifies dimensions and requirements for both open and closed suction catheters made
of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

  • Standard
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day