ANSI/AAMI/ISO 11607-1:2019
Current
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
24-05-2019
€157.50
Excluding VAT
This document specifies 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.
| DevelopmentNote |
New child AMD 1 2023 is added
|
| DocumentType |
Test Method
|
| ISBN |
978-1-57020-721-1
|
| Pages |
86
|
| ProductNote |
THIS STANDARD ALSO REFERS TO AATCC-127,AATCC-193 ,EDANA 170-1,EN 868,EN 868,ISTA 3A&3B,JIS P-8111,JIS P-8112,JIS P-8116,JIS P-8117,JIS P-8118,JIS P-8124,JIS P-8135,JIS P-8144,JIS P-8145, SS 876,TAPPI T255, TAPPI T256,TAPPI T403, TAPPI T410
New child AMD 1 2023 is added |
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| AAMI TIR17:2024 | Compatibility of materials subject to sterilization |
| ANSI/AAMI ST91:2021 | Flexible and semi-rigid endoscope processing in health care facilities |
| ISO 811:2018 | Textiles — Determination of resistance to water penetration — Hydrostatic pressure test |
| ISO 2493-1:2010 | Paper and board — Determination of bending resistance — Part 1: Constant rate of deflection |
| ISO 1924-3:2005 | Paper and board — Determination of tensile properties — Part 3: Constant rate of elongation method (100 mm/min) |
| 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 |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 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 |
| ISO 187:1990 | Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples |
| ISO 10993-1:2003 | Biological evaluation of medical devices — Part 1: Evaluation and testing |
| ISO 2233:2000 | Packaging — Complete, filled transport packages and unit loads — Conditioning for testing |
| ISO 186:2002 | Paper and board — Sampling to determine average quality |
| ISO 1924-2:2008 | Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min) |
| ISO 2859-1:1989 | Sampling procedures for inspection by attributes — Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| ISO 535:2014 | Paper and board — Determination of water absorptiveness — Cobb method |
| ISO 9001:2000 | Quality management systems — Requirements |
| ISO 534:1988 | Paper and board — Determination of thickness and apparent bulk density or apparent sheet density |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| ISO 1974:1990 | Paper — Determination of tearing resistance (Elmendorf method) |
| ISO 13845:2015 | Plastics piping systems — Elastomeric-sealing-ring-type socket joints for use with thermoplastic pressure pipes — Test method for leaktightness under internal pressure and with angular deflection |
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