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
