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UNI EN ISO 11607-1 : 2014

UNI EN ISO 11607-1 : 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

Superseded date

29-08-2022

Superseded by

UNI EN ISO 11607-1:2017

Published date

01-01-2014

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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PREMESSA ALLA NORMA
PREMESSA ALL'AGGIORNAMENTO A1
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 REQUISITI GENERALI
5 MATERIALI E SISTEMI DI BARRIERA STERILI
  PREFORMATI
6 REQUISITI DI PROGETTAZIONE E SVILUPPO PER I
  SISTEMI DI IMBALLAGGIO
7 INFORMAZIONI DA FORNIRE
APPENDICE A (informativa) - GUIDA AGLI IMBALLAGGI MEDICALI
APPENDICE B (informativa) - METODI DI PROVA NORMALIZZATI E
            PROCEDURE CHE POSSONO ESSERE UTILIZZATE
            PER DIMOSTRARE LA CONFORMITA AI REQUISITI
            DELLA PRESENTE PARTE DELLA ISO 11607
APPENDICE C (normativa) - METODO DI PROVA PER LA
            AL PASSAGGIO DELL'ARIA
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
             NORMA EUROPEA E I REQUISITI ESSENZIALI
             DELLA DIRETTIVA UE 93/42/CEE SUI DISPOSITIVI
             MEDICI
BIBLIOGRAFIA

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
U42.12
DevelopmentNote
Supersedes UNI EN 868-1. (07/2006) Italian version issued in NOVEMBER 2014. (11/2014)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

UNI/TR 11408 : 2011 GUIDE TO DESIGN, DEVELOPMENT AND CONTROL OF A RECONDITION PROCESS FOR REUSABLE MEDICAL DEVICES THAT SHALL BE STERILIZED BY STEAM

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
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
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
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
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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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