BS EN ISO 11607-1:2017 - TC Tracked Changes. Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

BS EN ISO 11607-1:2017 - TC

Tracked Changes. Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

Status : Withdrawn   Published : July 2019

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What is a tracked changes standard?

A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified. This version of the standard includes both a copy of the new standard, along with a track changes version.

What is this standard about?

BS EN ISO 11607-1 is the first of two international standards on how to ensure that medical devices packaging allows sterilization, provides physical protection and maintains sterility to the point of use. These standards also help users show compliance with the relevant EU regulations concerning medical devices.

This part deals with requirements and test methods, and is a tracked changes document which highlights the differences between the 2009 and the 2017 versions of this standard. It also includes a full “clean” version of the 2017 standard.

Who is this standard for?

  • Manufacturers of medical devices, including IVDs
  • Manufacturers of packaging materials and packaging systems for sterile devices
  • Healthcare facilities with in-house or contracted sterilization services

Why should you use this standard?

It specifies the most up-to-date 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.

It specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs and sterilization methods.

What’s changed since the last update?

The 2017 revision incorporates features intended to support the Medical Devices Regulation, particularly regarding an increased emphasis on the sterile barrier system for sterile medical devices. It also ensures harmonization across the industry by introducing standardized terminology and consistent international practice.

Specifically, the main highlighted changes in comparison with the 2009 version are: 

a)       Definitions have been aligned with BS EN ISO 11139:2018 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

b)      New requirements for the evaluation of usability for aseptic presentation of the medical device have been added

c)       A new section with requirements for revalidation in accordance with BS EN ISO 11607-2 has been added

d)      The Annex on test methods has been updated with various international test methods being added or deleted

e)      A new Annex with environmental considerations has been added

f)        A new Annex with guidance on ways to differentiate a sterile barrier system from protective packaging has been added

g)       It is best practice to inspect sterile barrier systems immediately prior to use to determine if breaches in integrity of the barrier are evident. The standard indicates that the instructions for use for sterile medical devices should include inspection for breaches of the integrity of the package prior to use.

Standard NumberBS EN ISO 11607-1:2017 - TC
TitleTracked Changes. Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
Publication Date31 July 2019
Withdrawn Date21 May 2020
Normative References(Required to achieve compliance to this standard)ISO 5636-5:2003, ISO 11607-2, ISO 5636-5
Informative References(Provided for Information)ASTM F2227, ASTM D3420, ISO 14971, ASTM D7386, ASTM F1980, ASTM F392, ISO 536, ISO 11607-1, ISO 5636-3, ASTM D257, ISO 18604, ISO 3689, TAPPI T566, ASTM D737, DIN 53121, TAPPI T256, JIS P-8118, ISO 15223-1, JIS T 0993-1, ISO 14025, F88M, ASTM F1927, AAMI ST65, ISO 18603, ASTM F2054, EN 13060, EN 13432, ISO 14044, EN 13431, ISO 535, ASTM F99, ASTM D3776–6M, JIS P-8144, ISTA 4A&4B, ISO 7000, JIS P-8117, AAMI TIR 65, ASTM D1922, TR 14062, ISO 17665-1, TAPPI T435, TAPPI T456, ASTM D5034, ASTM F2203, EN 13427, ASTM F2622, ASTM D4169, ISO 14001, ISO 534, ISO 11137 (all parts), ASTM F1140, TAPPI T494, ISO 9073-9, ASTM D3776?6M, ASTM F2096, ISO 2493-1, ISO 13485, JIS P-8124, TAPPI T460, ISO 186, 2559F, ISO 18601, EN 13428, ISO 14040, ASTM F1306, ASTM F3039, IEC 62366 (all parts), ASTM F2981, TAPPI T441, ASTM F2638, ASTM D3078, AATCC-127, ASTM D3786, ASTM D4332, ASTM F1307, EDANA 170-1, JIS P-8135, ISO 11607-2, TAPPI T536, ISO 14024, ASTM F2338, SS 876 0019, TAPPI T489, ISO 1924-3, ISO 50001, ISTA 3A&3B, ISO 187, ISO 2758, ASTM F2095, TAPPI T509, ASTM D4321, TAPPI T410, TAPPI T255, DIN 58953-6, TAPPI T551, ASTM
International RelationshipsEN ISO 11607-1:2017
DescriptorsPerformance, Performance testing, Packages, Medical equipment, Packaging materials, Seals, Quality assurance systems, Medical instruments, Sterilization (hygiene), Packaging, Test methods, Compatibility, Wrapping, Quality, Sterile equipment, Design
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme
ISBN978 0 539 05863 5
File Size1.698 MB

*To ask about withdrawn titles contact the
Customer Relations, +44 345 086 9001
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