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11.120.20 - Wound dressings and compresses

ICS 11.120.20 Details

Wound dressings and compresses

Sanitetni materiali, obveze in komprese

General Information

Parent
11.120 - Pharmaceutics

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Standardization Organization
Technical Committee
Directive
Mandate
50
SIST
SIST EN 17854:2024(Main)
Antimicrobial wound dressings - Requirements and test method
EN 17854:2024

This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.

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CEN
EN 17854:2024(Main)
Antimicrobial wound dressings - Requirements and test method
SIST EN 17854:2024

This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.

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SIST
SIST EN 13726:2024(Main)
Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility
EN 13726:2023

This document specifies test methods for the evaluation of aspects of absorption of wound dressings,
test methods for the evaluation of moisture vapour transmission rate of permeable film wound and
fixation dressings, and test methods to assess waterproofness and extensibility.

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CEN
EN 13726:2023(Main)
Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility
SIST EN 13726:2024

This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.

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SIST
SIST-TP CEN/TR 15831:2009(Main)
Method for testing compression in medical hosiery
CEN/TR 15831:2009

This document applies to medical compression hosiery and thrombosis prophylaxis hosiery.
An important property of hosiery is the compression it exerts on the limb. This document is intended to provide a reference for testing the compressive properties in medical hosiery.

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CEN
CEN/TR 15831:2009(Main)
Method for testing compression in medical hosiery
SIST-TP CEN/TR 15831:2009

This document applies to medical compression hosiery and thrombosis prophylaxis hosiery.
An important property of hosiery is the compression it exerts on the limb. This document is intended to provide a reference for testing the compressive properties in medical hosiery.

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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.

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SIST
SIST EN 14079:2003(Main)
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
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.

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SIST
SIST EN 1644-2:2000(Main)
Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
EN 1644-2:2000

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

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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.

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

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

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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.

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CEN
prEN 16756(Main)
Antimicrobial wound dressings - Requirements and test methods
oSIST prEN 16756:2014

This standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.

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SIST
oSIST prEN 16756:2014(Main)
Antimicrobial wound dressings - Requirements and test methods
prEN 16756

This standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.

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SIST
oSIST prEN 14079-1:2006
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
prEN 14079-1

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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SIST
oSIST prEN 14079-2:2006
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
prEN 14079-2

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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SIST
SIST EN 13726-1:2002/AC:2004(Amendment)
Test methods for primary wound dressings - Part 1: Aspects of absorbency
EN 13726-1:2002/AC:2003

AFNOR - Modification of F title

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

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

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SIST
SIST EN 13726-3:2003(Main)
Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
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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SIST
SIST EN 13726-1:2002(Main)
Test methods for primary wound dressings - Part 1: Aspects of absorbency
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.

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

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CEN
EN 13726-1:2002/AC:2003(Corrigendum)
Test methods for primary wound dressings - Part 1: Aspects of absorbency
SIST EN 13726-1:2002/AC:2004

AFNOR - Modification of F title

  • Corrigendum
    2 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.

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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 13726-2:2002(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.

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    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.

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

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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.

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SIST
SIST ENV 12719:2002(Main)
Medical thrombosis prophylaxis hosiery
ENV 12719:2001

This European Prestandard applies to medical thrombosis prophylaxis hosiery, knitted from threads made of natural fibres or synthetic fibres and elastic threads, which is used as a medical device for prophylaxis of venous thrombosis. The prestandard specifies requirements and test methods, except for custom-made hosiery.

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SIST
SIST ENV 12718:2002(Main)
Medical compression hosiery
ENV 12718:2001

This European Prestandard specifies requirements and gives test methods for medical compression hosiery, including custom-made hosiery (class 030606, EN 29999), knitted from threads made of natural fibres or synthetic fibres and elastic threads. It is applicable to medical compression hosiery which is used as a medical device for the treatment of venous and/or lymphatic diseases of the leg. This European Prestandard does not give requirements connected with the manufacture of hosiery.
NOTE   Manufacturing methods that have been shown by experience to be satisfactory are given for information in annex A.

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CEN
ENV 12719:2001(Main)
Medical thrombosis prophylaxis hosiery
SIST ENV 12719:2002

This European Prestandard applies to medical thrombosis prophylaxis hosiery, knitted from threads made of natural fibres or synthetic fibres and elastic threads, which is used as a medical device for prophylaxis of venous thrombosis. The prestandard specifies requirements and test methods, except for custom-made hosiery.

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    36 pages
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CEN
ENV 12718:2001(Main)
Medical compression hosiery
SIST ENV 12718:2002

This European Prestandard specifies requirements and gives test methods for medical compression hosiery, including custom-made hosiery (class 030606, EN 29999), knitted from threads made of natural fibres or synthetic fibres and elastic threads. It is applicable to medical compression hosiery which is used as a medical device for the treatment of venous and/or lymphatic diseases of the leg. This European Prestandard does not give requirements connected with the manufacture of hosiery.
NOTE   Manufacturing methods that have been shown by experience to be satisfactory are given for information in annex A.

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    43 pages
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CEN
EN 600:1996(Main)
Natural rubber latex male condoms
SIST EN 600:2000

This European Standard specifies requirements for male condoms made from compounded natural rubber latex (referred to in this European Standard as condoms) supplied to consumers and designed to assist in the prevention of sexually transmitted diseases and for contraceptive purposes.   Note 1:  Guidance on the determination of properties of condoms that have been stored after purchase is given in Annex A, which does not form a normative part of this European Standard.  Note 2: Recommendations on the storage of packaged condoms are given in Annex B, which does not form a normative part of this European Standard.

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