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CEN

CEN/TC 205/WG 9 - Test methods for materials for use in compresses

To be responsible to CEN/TC 205 for the preparation of draft standards for compresses and wound dressings.

Test methods for materials for use in compresses

To be responsible to CEN/TC 205 for the preparation of draft standards for compresses and wound dressings.

General Information

Status
Inactive
Parent
CEN/TC 205 - Non-active medical devices
Standardization Organization
ICS
Directive
Mandate
50
CEN
EN 14079:2003(Main)
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
SIST EN 14079:2003

This standard describes the requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauzes. The standard does not consider gauzes impregnated with a pharmaceutical substance.

  • Standard
    18 pages
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CEN
EN 1644-2:2000(Main)
Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
SIST EN 1644-2:2000

This Part of EN 1644 specifies physical and chemical tests for the evaluation of finished nonwoven compresses.

  • Standard
    28 pages
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CEN
EN 1644-1:1997(Main)
Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
SIST EN 1644-1:2000

This part of EN 1644 describes physical and chemical tests for the evaluation of nonwovens used as materials for compresses for medical use.

  • Standard
    19 pages
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CEN
prEN 14079-2(Main)
Non-active medical devices - Properties for compresses and wound packing products for medical use - Part 2: Test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
oSIST prEN 14079-2:2006

Part 2 of prEN14079 specifies physical and chemical tests for the evaluation of absorbent cotton gauze and absorbent cotton and viscose gauze compresses and wound packing products.
Specific tests and requirements for absorbent cotton gauze and cotton and viscose gauzes used in the manufacture of compresses and wound packing products are covered in prEN 14079-1, which can be used in conjunction with this part of the standard.
NOTE 1   Biocompatibility aspects are not covered in this standard, but are addressed in EN ISO 10993.
NOTE 2   Bioburden determination methods are not covered by this standard, but are addressed in EN XXX.

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    12 pages
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CEN
prEN 14079-1(Main)
Non-active medical devices - Properties for compresses and wound packing products for medical use - Part 1: Test methods and requirements for absorbent cotton gauze and absorbent cotton and viscose gauzes used in the manufacturing of compresses and wound packing products
oSIST prEN 14079-1:2006

This European Standard describes the physical and chemical test methods with requirements for the evaluation of absorbent cotton gauzes and absorbent cotton and viscose gauzes used as materials for compresses and wound packing products for medical use. X-ray detectable components are included.

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    33 pages
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CEN
EN 13726-3:2003(Main)
Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
SIST EN 13726-3:2003

This European Standard describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.

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    6 pages
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CEN
EN 13726-4:2003(Main)
Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
SIST EN 13726-4:2003

This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.

  • Standard
    7 pages
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CEN
EN 13726-2:2002(Main)
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
SIST EN 13726-2:2002

Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate of permeable film primary wound dressings.

  • Standard
    9 pages
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CEN
EN 13726-1:2002(Main)
Test methods for primary wound dressings - Part 1: Aspects of absorbency
SIST EN 13726-1:2002

Part 1 of EN 13726 specifies test methods recommended for the evaluation of some aspects of absorbency of primary wound dressings.

  • Standard
    16 pages
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CEN
EN 13726-6:2003(Main)
Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control
SIST EN 13726-6:2003

This European Standard describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.

  • Standard
    8 pages
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