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As 4369.1-1996 Surgical Dressings Single-Use X-Ray Detectable Abdominal Sponges
As 4369.1-1996 Surgical Dressings Single-Use X-Ray Detectable Abdominal Sponges
1—1996
Australian Standard
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Surgical dressings
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Australian Standard
This is a free 5 page sample. Access the full version at http://infostore.saiglobal.com.
Surgical dressings
PREFACE
This Standard was prepared by the Standards Australia Committee MS/5, Institutional
Supplies. It is one of a series of Standards for surgical dressings and kindred products.
In preparing the Standard, consideration was given to the requirements of the British,
European and United States Pharmacopoeias.
CONTENTS
Page
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STANDARDS AUSTRALIA
Australian Standard
Surgical dressings
1 SCOPE This Standard sets out requirements for single-use X-ray detectable
absorbent abdominal sponges for X-ray detectable surgical use. It applies to sterile and
non-sterile sponges.
Standard:
AS
1079 Packaging of items (sterile) for patient care
1079.1 Part 1: Selection of packaging materials for goods undergoing sterilization
2835 Absorbent woven gauze
2835.1 Part 1: Cotton
2835.2 Part 2: Cotton-viscose blends
2836 Methods of testing surgical dressings and surgical dressing materials
2836.4 Part 4: Method for the determination of size
4187 Code of practice for cleaning, disinfecting and sterilizing reusable medical and
surgical instruments and equipment, and maintenance of associated environments
in health care facilities
The British Pharmacopoeia, 1993 edition
Therapeutic Goods Administration, Commonwealth Department of Health, Housing and
Community Services, Canberra
Therapeutic Goods Order (TGO) No. 11. Standard for sterile therapeutic goods
Therapeutic Goods Order (TGO) No. 37. General requirements for labels for therapeutic
goods
3 DEFINITIONS For the purpose of this Standard, the definitions below shall apply.
3.1 Abdominal sponge—white absorbent woven gauze, or non-woven material, or a
combination of woven gauze and non-woven material folded into a rectangle or square,
that is sewn or bonded around the open sides. The sponge includes an X-ray detectable
marker and may or may not have a tape attached to one corner.
3.2 Length — the longest side of the sponge.
3.3 Packs
3.3.1 Unit packs—a pack providing a microbial barrier and containing five (5) sterile
abdominal sponges.
3.3.2 Multiple packs—a pack containing one or more sterile unit packs or a pack
containing one or more non-sterile abdominal sponges.
3.3.3 Store pack—a pack containing one or more multiple packs.
3.4 X-ray detectable marker — a monofilament thread, or multifilament yarn, or a
block, or a continuous strip, or a similar insertion, which is opaque to X-rays.
COPYRIGHT
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