BS EN ISO 11607-1:2020

BS EN ISO 11607-1:2020

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

Status : Current, Under review   Published : January 2020



What is BS EN ISO 11607-1:2020 about?

This is the first of two international standards written to ensure that terminally sterilized medical device packaging allows sterilization, provides physical protection and maintains sterility to the point of use. BS EN ISO 11607-1:2020 looks at requirements for packaging materials, as well as sterile barrier systems and packaging systems.

Who is BS EN ISO 11607-1:2020 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 BS EN ISO 11607-1:2020?

The development and construction of packaging systems for terminally sterilized medical devices is complicated and critical to patient safety. BS EN ISO 11607-1:2020 specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until the point of use.

Use of the standard:

  • Supports compliance with the General Safety and Performance Requirements (GSPR) contained in the EU MDR[WT1] 
  • Supports increased focus internationally on requirements for sterile barrier systems for sterile medical devices
  • Tackles the usability of packaging as well as its physical and microbiological performance
  • Promotes state of the art procedures

NOTE: BS EN ISO 11607-1:2020 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

What’s new about BS EN ISO 11607-1:2020?

The standard was revised to harmonize with the General Safety and Performance Requirements (GSPR) contained in the EU MDR, which stipulate that a design allow for easy and safe handling and prevent microbial contamination, and that the integrity of that packaging is clearly evident to the final user.

Other changes to Part 1 include:

a)      Definitions have been aligned with the latest version of ISO 11139

b)     New requirements added for the evaluation of usability for aseptic presentation

c)      New requirements added for the inspection of sterile barrier system integrity prior to use

d)     A new subclause added with requirements for revalidation in line with ISO 11607-2

e)     Annex B updated and various national, international and European test methods added or deleted

f)       A new Annex D added with environmental considerations

g)      A new Annex E added with draft guidance on ways to differentiate a sterile barrier system from protective packaging

Standard NumberBS EN ISO 11607-1:2020
TitlePackaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
StatusCurrent, Under review
Publication Date20 January 2020
Normative References(Required to achieve compliance to this standard)ISO 11607-2, ISO 5636-5
Informative References(Provided for Information)TR 14062, ASTM F2622, ASTM D4332, BS 6256, ISO 14001, TAPPI T566, JIS P-8135, ASTM F1140, TAPPI T256, EN 285, ISO 1974, ISO 535, ASTM F2228, ASTM F3039, F88M, EN 13427, ISO 11607-1, TAPPI T403, ASTM D7386, ISO 187, ISO 9198, ISO 5636-3, ISO 14044, ISO 14040, ASTM D3786, ISTA 4A&4B, TAPPI T460, ASTM D4321, TAPPI T411, ISO 10993-1, ISO 6588-2, ISO 11137 (all parts), ASTM F2338, AAMI ST90, TAPPI T410, SS 876 0019, ISO 14971, ISO 18606, ASTM D1424, ASTM F1307, ASTM D3985, ISO 6588-1, AATCC-127, ISTA 7D, TAPPI T441, EN 13431, JIS T 0993-1, ASTM F2251, ASTM D1709, ISO 14025, ISO 2493-1, ISO 9001, ASTM F2097, ISTA 3A&3B, ISO 15223-1, ISO 11607-2, AAMI TIR 65, ISO 14024, ASTM D4169, TAPPI T435, JIS P-8116, TAPPI T489, ASTM F2638, ASTM F2227, ASTM F2096, ISO 2233, ASTM F1927, ASTM F392, JIS P-8111, TAPPI T564, ISO 534, ISO 2493-2, F1886M, EDANA 170-1, ISO 9073-9, TAPPI T255, ISO 186, EN 13430, ISO 4180, ISO 18602, ASTM F1929, ISO 7000, BS 6524, ASTM D737, ASTM D3078, TAPPI T551, ISO 14937, ISO 1924-3, TAPPI T536, ISO 18604, EN 13060, ASTM D257, ASTM F2252, ISO 536, ASTM F2825, ASTM F1980, JIS P 8133, ASTM F99, AST
ReplacesBS EN ISO 11607-1:2017
International RelationshipsEN ISO 11607-1:2020,ISO 11607-1:2019
Amended ByCorrigendum, March 2020
DescriptorsSeals, Packages, Quality, Packaging materials, Performance testing, Test methods, Design, Quality assurance systems, Sterilization (hygiene), Medical instruments, Sterile equipment, Packaging, Wrapping, Compatibility, Medical equipment, Performance
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 13191 8
File Size3.532 MB

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