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Sterile Packaging Standards

Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.

 

TS EN 76 Packaging - For certain foods with ready packaging - Capacity of glass and metal containers

 TS EN ISO 11607-2 Packaging for finally sterilized medical devices - Part 2: Validation features for forming, sealing and assembly processes

TS EN ISO 11607-1 Packaging of medical devices - Finally sterilized - part 1: Materials, specifications for sterile barrier systems and packaging systems

TS EN ISO 11607-1 Packaging for finally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

TS EN 868-5 Packaging materials for finally sterilized medical devices - Part 5: Self-resealable bags and rolls made of porous material and plastic film - Specifications and test methods

TS EN 868-8 Packaging materials for finally sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers according to EN 285 - Specifications and test methods

TS EN 868-3 Packaging materials and systems for medical devices to be sterilized - Part 3: Paper bags (en 868-4) and paper and roll (en 868-5)

TS EN 868-9 Packaging materials and systems for medical devices to be sterilized - Part 9: Uncoated non-woven polyolefin materials for the production of heat-sealable bags, rolls and closures - Specifications and test methods

TS EN 868-3 Packaging materials and systems for medical devices to be sterilized - Part 3: Paper bags (en 868-4) and paper and roll (en 868-5)

TS EN 868-10 Packaging for medical devices for final sterilization - Part 10: Adhesive coated nonwoven polyolefin materials - Requirements and test methods

TSE CEN ISO / TS 16775 Packaging for the last sterilized medical device - Guidance on the application of ISO 11607-1 and ISO 11607-2

Packaging of medical devices - Finally sterilized - part 11607: Materials, specifications for sterile barrier systems and packaging systems TS EN ISO 1-1 / A1

Packaging of medical devices - Finally sterilized - Part 11607: Validation requirements for forming, sealing and joining processes TS EN ISO 2-1 / A2

Packaging of medical devices - Finally sterilized - Part 11607: Specifications for materials, sterile barrier systems and packaging systems (ISO 1-1: 1 / Amendment 11607: 1) TS EN ISO 2006-1 / A2014

Packaging of medical devices - Finally sterilized - Part 11607: Validation requirements for forming, sealing and joining processes (ISO 2: 1 / Amendment 2: 11607) TS EN ISO 2-2006 / A1

TS EN 868-6 Packaging materials and systems - For medical devices to be sterilized - Part 6: Paper for the manufacture of packaging for medical use to be sterilized by ethylene oxide or irradiation - Specifications and test methods

tst EN 868-6 Packaging materials and systems - For medical devices to be sterilized - Part 6: Paper for the production of packaging for medical use to be sterilized by ethylene oxide or irradiation - Specifications and test methods

tst CEN ISO / TS 16775Packaging for the final sterilized medical device - Guide to the implementation of ISO 11607-1 and ISO 11607-2

TS EN 868-2 Packaging for medical devices for final sterilization - Part 2: Sterilization wraps - Requirements and test methods

TS EN 868-7 Packaging materials and systems - Part for medical devices to be sterilized 7: Adhesive coated paper for the production of heat-sealable packages for sterilization by ethylene oxide or irradiation for medical use - Specifications and test methods

TS EN 868-10 Packaging materials and systems for medical devices to be sterilized - Part 10: Adhesive coated nonwoven polyolefin materials for the manufacture of heat-sealable bags, reels and closures - Rules and test methods

TS EN 868-4 Packaging materials and systems - For medical devices to be sterilized - Part 4: Paper bags - Specifications and test methods

TS EN ISO 9073-18 Textiles - Test methods for nonwovens - Part 18: Determination of tensile strength and elongation of nonwovens - Grab method

TS EN ISO 11607-2 Packaging of medical devices - Finally sterilized - Part 2: Validation requirements for forming, sealing and joining processes