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SN/T 3062.3-2011: Packaging materials for terminally sterilized medical devices for import. Part 3: Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
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SN/T 3062.3-2011	English	184	Add to Cart	3 days [Need to translate]	Packaging materials for terminally sterilized medical devices for import. Part 3: Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods

SN/T 3062.3-2011: Packaging materials for terminally sterilized medical devices for import. Part 3: Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods

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Packaging materials for terminally sterilized medical devices for import.Part 3. Sealable pouches and reels of porous materials and plastic film construction.Requirements and test methods People's Republic of China Entry-Exit Inspection and Quarantine Standards Imports of medical equipment sterilization packaging Part 3. breathable material composed of a plastic film Sealable bags and coil combination of requirements and test methods Part 3. Sealablepouchesandreelsofporousmaterialsand (BSEN868-5.2009, Sealablepouchesandreelsofporousmaterialsand plasticfilmconstruction-Requirementsandtest, IDT) Issued on. 2011-09-09 2012-04-01 implementation People's Republic of China The State Administration of Quality Supervision, Inspection and Quarantine released

Foreword

SN/T 3062 "import medical equipment sterilization packaging" is divided into four parts. --- Part 1. forming, sealing and assembly processes to confirm the request; --- Part 2. Paper bags - Requirements and test methods; --- Part 3. sealable bags and coil combination requirements and test methods breathable material and plastic film composition; --- Part 4. Materials and preformed sterile barrier system requirements. This section SN/T 3062 Part 3. This section drafted in accordance with GB/T 1.1-2009 given rules. This section is identical with EN868-5.2009 "Packaging for terminally sterilized medical devices Part V. permeable plastic materials and film composition Seal bag and the volume requirements and test methods "(in English). When using EN868-5 made editorial changes, the main differences are as follows. --- Modify the standard structure, format, chapter is structured; --- Remove the EN868-5.2009 in the preface, appendices A and references. --- EN868-5. Appendix BF in 2009 as part of the AE. This section proposed and managed by the National Certification and Accreditation Administration Committee. This section was drafted by. People's Republic of China Beijing Entry-Exit Inspection and Quarantine Bureau. The main drafters of this section. Qi Jing, Wang Fei, Li Guoqing, Tangshu Tian, Liu Chuan, Ning Ma, leaf light, Li Wei. Imports of medical equipment sterilization packaging Part 3. breathable material composed of a plastic film Sealable bags and coil combination of requirements and test methods

1 Scope

SN/T 3062 provisions of this part of the packaging used for sterilization of medical devices sealed bags and sheets - Test methods and requirements. The main purpose of this section is to establish appropriate standards for the sterile barrier system or packaging to ensure sterility of the sterilization of medical devices. Note 1. The packaging is required pollution by manufacturers and consumers to decide. All devices are specified in this part-time use. Note 2. When additional materials used within the sterile barrier system in order to achieve another purpose, such as to improve the organization, drying or disinfection (such as. corrosion within the band, filters, indicating , A packing list, inner liner, brochures, tray mats or medical devices outside the additional package), will implement additional requirements include whether these materials It can be used in the verification activities and the like.

2 Normative references

The following documents for the application of this document is essential. All the reference documents date, only applies to date version of this document. For undated references the latest edition (including any amendments) applies to this document. ASTMD882.1995 Plastic Sheet Standard Test Method for Tensile Properties EN868-2 Packaging for terminally sterilized medical devices - Part 2. Sterilization wrap material requirements and test methods EN868-3 Packaging for terminally sterilized medical devices - Part 3. Paper bags and coils production requirements and test methods EN868-6 Packaging for terminally sterilized medical devices - Part 6. Paper low temperature sterilization processes - Requirements and test methods EN868-7 Packaging for terminally sterilized medical devices - Part 7. Low-temperature sterilization processes with a sealable adhesive paper requirements and test methods EN868-9 Packaging for terminally sterilized medical devices - Part 9. non-adhesive polyolefin non-woven fabric material requirements and test methods EN868-10 Packaging for terminally sterilized medical devices - Part 10. Sealing adhesive polyolefin non-woven fabric material requirements and test methods ENISO 11140-1 Sterilization of health care products - Chemical indicators - Part I. General requirements (ISO 11140-1.2005) 2006 Packaging for terminally sterilized medical devices - Part 1.. ENISO 11607-1 materials, sterile barrier systems and packaging systems (ISO 11607-1.2006) ISO 8601 data storage and exchange of information in the form of representation · exchange · date and time

3 Terms

ENISO 11607-1.2006 and defined the following terms and definitions apply to this section. 3.1 Healthcare healthcarefacility Where patients receive medical treatment and medical instruments are sterilized final place. For example. hospitals and dental clinics. ...