iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 11070:2014/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 intravaskuläre 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
Publication Date
03-Jul-2018
Withdrawal Date
30-Jan-2019
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
04-Jul-2018
Completion Date
04-Jul-2018
Ref Project
SIST EN ISO 11070:2015/A1:2018 - Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Relations

Amends
EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
Effective Date
21-Dec-2016

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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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

CEN
EN ISO 10555-1:2023(Main)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)
SIST EN ISO 10555-1:2024

This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.
This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.

  • Standard
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10555-4:2023(Main)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
SIST EN ISO 10555-4:2024

This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE            Guidance on the selection of balloon materials is given in Annex G.

  • Standard
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
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)
SIST 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
CEN
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)
SIST 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
CEN
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)
SIST 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
CEN
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, Corrected version 2023-01)
SIST 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
CEN
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)
SIST 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 double-ended 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
CEN
EN ISO 7886-3:2020(Main)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
SIST EN ISO 7886-3:2020

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.

  • Standard
    24 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7886-2:2020(Main)
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)
SIST EN ISO 7886-2:2020

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 20695:2020(Main)
Enteral feeding systems - Design and testing (ISO 20695:2020)
SIST EN ISO 20695:2020

This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories.
This document is not applicable to oral syringes.

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