BS EN ISO 11607-2:2017 - TC Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

BS EN ISO 11607-2:2017 - TC

Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

Status : Current   Published : August 2019


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 11607-2 is the second 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 second part specifies validation requirements, 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 requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

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)       Terms and definitions for “process variable”, “process parameter” and “monitoring of processes” have been added and all definitions have been aligned with the latest version of BS EN ISO 11139

b)      The terminology of “critical” process parameters has been discontinued and the concept of a process specification has been introduced to include all elements required to manufacture a product that consistently meets specifications

c)       It now supports the explicit requirement for validation of the sealing of the sterile barrier system in BS EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

Standard NumberBS EN ISO 11607-2:2017 - TC
TitleTracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
Publication Date09 August 2019
Normative References(Required to achieve compliance to this standard)ISO 11607-1, ISO 11607-1:2018
Informative References(Provided for Information)ISO 11607-2, ISO 186, ISO 9001, AAMI ST65, ISO 14971, EN 13795-1, EN 868-8, DIN 58953-9, DIN 58953-7, TS 16775, AAMI ST90, AAMI ST77, ISO 11607-1, GAMP 5, DIN 58953-8, ISO 2859-1, ISO 2859-1:1999, ISO 186:2002, EN 868-5:1999, DIN 58953-8:2003 (G), EN 13795-1:2002, ISO 13485:2016, ISO 11139:2018, ISO/TS 11139:2006, ISO 9001:2000, DIN 58953-7:2003 (G), EN 868-6:1999, EN 868-8:1999, DIN 58953-9:2000 (G), ISO 13485:2003, ISO 9000:2000
International RelationshipsEN ISO 11607-2:2017
Draft Superseded By17/30351720 DC
DescriptorsPackages, Sterile equipment, Packaging, Medical instruments, Performance, Quality, Sealing processes, Seals, Acceptance (approval), Verification, Performance testing, Wrapping, Packaging materials, Quality assurance systems, Medical equipment, Packaging processes, Sterilization (hygiene)
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens
ISBN978 0 539 06017 1
File Size1.624 MB

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