Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods
YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers - Requirements and test methods
1 Scope
This part of YY/T 0698 specifies requirements and test methods for re-usable sterilization containers for steam sterilizers.
This part does not add requirements to the general requirements specified in ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 may be used to demonstrate compliance with one or more but not all of the requirements of ISO 11607-1.
The containers specified in this part are intended to be used as packaging systems for the sterilization of medical devices in a steam sterilizer conforming to EN 2852) and then for the transportation and storage of the devices.
Note 1: When such a container is intended to be used in a steam sterilizer not conforming to EN 285, the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g., operating temperature.
Note 2: When a device needs to be wrapped in multiple layers to meet the general requirements, the device should be packaged with sterilized packaging materials (such as those specified in other parts of this standard) first.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0698. For dated references, subsequent amendments (excluding corrections) to, or revisions of, any of these publications do not apply to this part. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 1220 Stainless steel bars
GB/T 5783-2000 Hexagon head bolts - Full thread (eqv ISO 4017:1999)
GB/T 15596 Plastics - Determination of changes in colour and variations in properties after exposure to daylight under glass, natural weathering or artificial light (GB/T 15596-1995, eqv ISO 4582:1980)
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers
3 Terms and definitions
For the purposes of this part of YY/T 0698, the terms and definitions given in ISO 11607-1 and EN 285 apply.
4 Requirements
4.1 General
The requirements of ISO 11607-1 shall apply.
Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
6 Test methods
Annex A (Informative) Guidance on dimensions
Annex B (Normative) Handle strength test
Annex C (Normative) Stacking test
Annex D (Normative) Stacking device capability test
Annex E (Normative) Determination of sterilization performance
Annex F (Normative) Load dryness tests
Annex G (Informative) Guidance on determination of useful life
Bibliography
