BS EN ISO 11607-1:2017 pdf free.Packaging for terminally sterilized medical devices -Part1:Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607 consists of the following parts, under the general title Packaging for terminally sterilized
medical devices:
— Part 1: Requirements for materials, sterile barrier systems and packaging systems
— Part 2: Validation requirements for forming, sealing and assembly processes
This part of Iso 11607 specifies 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.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.
This part of ISO 11607 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.
4 General requirements
4.1 General
Compliance with one or more requirements of this part of ISO 11607 may be demonstrated by using one or more parts of the series EN 868-2 to EN 868-10.
4.2 Quality systems
4.2.1 The activities described within this part of ISO 11607 shall be carried out within a formal quality system.
NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirements may be specified by a country or region.
4.2.2 It shall not be necessary to obtain third-party certification of the quality system to fulfil the requirements of this part of ISO 11607.
4.2.3 Health care facilities shall consider using the quality system required by their country or region.
4.3 Sampling
The sampling plans used for selection and testing of packaging systems shall be applicable to packaging systems being evaluated. Sampling plans shall be based upon statistically valid rationale.
NOTE Examples of suitable sampling plans are given in ISO 2859-1 or ISO 186. Additional sampling plans may be specified by countries or regions.
4.4 Test methods
4.4.1 All test methods used to show compliance with this part of Iso 11607 shall be validated and documented.
NOTE Annex B contains a list of suitable test methods.
4.4.2 The test method validation shall demonstrate the suitability of the method as used. The following elements shall be included:
— establishment of a rationale for the selection of the appropriate tests for the packaging system;
— establishment of acceptance criteria;
NOTE Pass/fail is a type of acceptance criterion.
— determination of test method repeatability;
— determination of test method reproducibility; and
— establishment of test method sensitivity for integrity tests.
4.4.3 Unless otherwise specified in the test methods, test samples shall be conditioned at (23 ± 1) °C and (50 ± 2) % relative humidity for a minimum of 24 h.
4.5 Documentation
4.5.1 Demonstration of compliance with the requirements of this part of ISO 11607 shall be documented.
4.5.2 All documentation shall be retained for a specified period of time. The retention period shall consider factors such as regulatory requirements, expiry date and traceability of the medical device or sterile barrier system.BS EN ISO 11607-1:2017 pdf free download.