I.S. EN ISO 11607-1:2017

Superseded

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)

Available format(s)

Hardcopy , PDF

Superseded date

01-23-2020

Published date

08-06-2017

Publisher

National Standards Authority of Ireland

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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging
  systems
7 Information to be provided
Annex A (informative) - Guidance on medical packaging
Annex B (informative) - Standardized test methods and
        procedures that may be used to demonstrate
        compliance with the requirements of this part of
        ISO 11607
Annex C (normative) - Test method for resistance of
        impermeable materials to the passage of air
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 93/42/EEC [OJ L 169] aimed to be
         covered
Annex ZB (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 90/385/EEC [OJ L 189] aimed to be
         covered
Annex ZC (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 98/79/EC [OJ L 331] aimed to be
         covered

Defines the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

Committee	TC 198
DevelopmentNote	Supersedes I.S. EN 868-1. (07/2006)
DocumentType	Test Method
Pages	48
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN ISO 11607-1:2020 I.S. EN ISO 11607-1:2017&LC:2017
Supersedes	I.S. EN ISO 11607-1:2009

Standards	Relationship
ISO 11607-1:2006	Identical
EN ISO 11607-1:2017	Identical
NS EN ISO 11607-1 : 2017	Identical
NBN EN ISO 11607-1 : 2009 + A1 2014	Identical
UNE-EN ISO 11607-1:2017	Identical
DIN EN ISO 11607-1:2014-11	Identical
UNI EN ISO 11607-1 : 2014	Identical
BS EN ISO 11607-1 : 2009	Identical

EN 13795-1:2002+A1:2009	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
EN 868-5:2009	Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
EN 868-1 : 1997	PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
ISO 5636-1:1984	Paper and board Determination of air permeance (medium range) Part 1: General method
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017	Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
AAMI ST65:2008(R2018)	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
ISO 5636-2:1984	Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method
ISO 5636-5:2013	Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
EN 552:1994/A2:2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 186:2002	Paper and board — Sampling to determine average quality
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015	Quality management systems — Requirements
EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
ISO 13683:1997	Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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I.S. EN ISO 11607-1:2017

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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