YY/T 0698.2-2009 in English

SUPERSEDED

Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

Issued on:2009-06-16
Implemented on:2010-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $140.00
$136.00

Standard No:	YY/T 0698.2-2009
Document status:	SUPERSEDED
Superseded by:	YY/T 0698.2-2022 Packaging materials for final sterilized medical devices-Part 2: Requirements and test methods for sterilized packaging materials
Superseded on:	2023-10-01
Title in English:	Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Title in Chinese:	最终灭菌医疗器械包装材料第2部分：灭菌包裹材料要求和试验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2009-06-16
Implemented on:	2010-12-01
Chinese Classification:	C31-General and microsurgical devices
Professional Classification:	YY-Pharmaceutics
Related Keywords:	test method test methods air gb/t gb/t spray test
Related Topics:	Packaging Materials Box Sterilization Method Box + Sterilization + Method YY T 0698.2 2009 Final Medical Device Packaging Materials Medical Device Sterilization Inspection Medical Device Packaging Materials Test Methods for Sterile Medical Device Packaging Part 18 Medical Device Packaging Materials Medical Packaging Materials Medical Device Packaging New Pharmaceutical Packaging Materials Class I Medical Device Packaging Requirements Raw material packaging requirements Medical Device Packaging Packing material terminally sterilized food Terminally sterilized and non-terminal sterilized Terminally Sterilized Medical Devices Sterilizer medical accident analysis Centrifuge sterilization method Fire Resistant Package Specification Requirements Non-terminal sterilization methods for medical devices Common sterilization methods for surgical instruments and accessories Sterilization method of ultra-clean clothes Abscisic acid sterilization method Sterilization and bandaging method for wide-mouth bottles Hot water sterilization method Sterilization methods and materials commonly used in cell engineering Sterilization methods for vaccination needles Medical device sterilization packaging standards and requirements

Packaging materials for terminal sterilized medical devices -
Part 2: Sterilization wrap - Requirements and test methods

1 Scope

This part of YY/T 0698 specifies the general requirements and test methods for materials of preformed barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

No requirements are added into this part with respect to the general requirements of ISO 11607-1, so the specific requirements in 4.2 may be used to prove that one or more requirements of ISO 11607-1, but not all of them, are met.

Notes:

1 According to the intended use specified by the manufacturer, the materials may also be suitable for other sterile fields or suitable for surgical drapes specified in YY/T 0506 series standards.

2 According to the intended use specified by the manufacturer, the materials may also be suitable for container filters or as wrap in containers, so the additional requirements and/or others may apply. See YY/T 0698.8.

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), or revisions, of any of these publications do not apply to this part of YY/T 0698. However parties to agreements based on this part of YY/T 0698 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 451.2 Paper and board - Determination of grammage (GB/T 451.2-2002; eqv ISO 536: 1995)
GB/T 454 Paper - Determination of bursting strength (GB/T 454-2002; idt ISO 2758: 2001)
GB/T 455 Paper and board - Determination of tearing resistance (GB/T 455-2002; eqv ISO 1974: 1990)
GB/T 458 Paper and board - Determination of air permeance (GB/T 458-2008; ISO 5636-2: 1984; ISO 5636-3: 1992; ISO 5636-5: 2003, MOD)
GB/T 465.1 Paper and board - Determination of bursting strength after immersion in water (GB/T 465.1-2008; ISO 3689: 1983, IDT)
GB/T 465.2 Paper and board - Determination of tensile strength after immersion in water (GB/T 465.2-2008; ISO 3781: 1983, IDT)
GB/T 1540 Paper and board - Determination of water absorption - Cobb method(GB/T 1540-2002; neq ISO 535: 1991)
GB/T 1545.2 Paper, board and pulp - Determination of pH of aqueous extracts (GB/T 1545.2-2003; mod ISO 6588: 1981)
GB/T 2678.6 Paper, board and pulp - Determination of water soluble sulphates (Conductimetric titration method)(GB/T 2678.6-1996; eqv ISO 9198: 1989)
GB/T 3917.1-1997 Textiles - Tear properties of fabrics - Part 1: Determination of tear force - Ballistic pendulum method (Elmendorf)(GB/T 3917.1-1997; neq ISO/DIS 13937-1: 1995)
GB/T 4744 Textile fabrics - Determination of resistance to water penetration - Hydrostatic pressure test(GB/T 4744-1997; eqv ISO 811: 1981)
GB/T 4745-1997 Textile fabrics - Determination of resistance to surface wetting - Spray test(GB/T 4745-1997; eqv ISO 4920: 1981)
GB/T 5453-1997 Textiles - Determination of the permeability of fabrics to air
GB/T 7408 Data elements and interchange formats - Information interchange - Representation of dates and times (GB/T 7408 2005; ISO 8601: 2000, IDT)
GB/T 7742.1 Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension (GB/T 7742.1-2005; ISO 13938-1: 1999, MOD)
GB/T 7974-2002 Paper, board and pulp - Measurement of brightness - Diff/Geometry (neq ISO 2470: 1999)
GB/T 12914 Paper and board - Determination of tensile properties (GB/T 12914-2008; ISO 1924-2: 1994, MOD)
ISO 6588-2: 2005 Paper, board and pulps - Determination of pH of aqueous extracts - Part 2: Hot extraction
ISO 9073-3 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
ISO 9073-9 Textiles - Test methods for nonwovens - Part 9: Determination of drapability including drape coefficient
ISO 9197 Paper, board and pulps - Determination of water-soluble chlorides
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information supplied by the manufacturer
Annex A (Normative) Method for the determination of water repellency
Annex B (Normative) Method for the determination of pore size
Annex C (Normative) Test method for the determination of drapability
Annex D (Normative) Method for the determination of salt water repellency
Bibliography

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