C48 医用卫生用品 标准查询与下载

ASTM F2848-10 医用级超高分子量聚乙烯纱线的标准规范

1.1 This specification covers ultra-high molecular weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. 1.2 This standard is intended to describe the required properties and the procedures to be followed for testing UHMWPE yarns as raw materials for medical devices. This specification does not purport to address the testing that is needed for medical devices or components of medical devices that are fabricated from the raw materials specified herein. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 The following precautionary caveat pertains only to the test method portion, Section 6, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns

ASTM D7102-10 测定无菌医用手套上的内毒素的标准指南

This guide establishes a standard sample preparation method and provides a description of four established and recognized test methods for the determination of endotoxin on medical gloves. If interferences in a sample yield suspect results, a second method should be used. This guide is appropriate for testing final product that has been subjected to all processes that could influence the final endotoxin level (either microbial contamination or processing agents/raw materials contaminated with endotoxin). As raw materials and processing conditions vary from lot to lot with regard to these parameters, it is appropriate to test for endo-toxin on a routine basis if a product endotoxin claim is to be made (for example, non-pyrogenic). The user may find it beneficial to incorporate endotoxin testing for vulnerable areas of their manufacturing process as an alert mechanism.1.1 This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate. 1.2 As bacteria may continue to grow on non-sterile gloves, reportable endotoxin levels are only appropriate for gloves labeled as sterile. Because most environments contain endotoxin, once a box of gloves is opened and the gloves are manipulated, endotoxin levels will increase making it inappropriate to report endotoxin levels on boxed gloves (ex. examination gloves). This is true even if the box had undergone sterilization prior to distribution. 1.3 This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations. 1.4 This guide is not applicable to the determination of pyrogens other than bacterial endotoxins. 1.5 The sample preparation method described must be used regardless of the test method selected. This method does not describe laboratory test method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed. 1.6 The safe and proper use of medical gloves is beyond the scope of this guide. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

ASTM F702-10 医用聚砜树脂的标准规范

1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,4–phenylene)) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for medical applications. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. 1.3 The standard allows for designation of polysulfone resin for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies. 1.4 The properties included in this specification are those applicable for unfilled polysulfone (PSU) polymers with the addition of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives, as well as polymer blends which contain PSU, or reclaimed materials, are not covered by this specification. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Polysulfone Resin for Medical Applications

KS M ISO 11193-2:2009 一次性医用检查手套.第2部分:聚乙烯(氯乙烯)制成的手套规范

이 표준은 의학적 진찰과 진단 또는 치료 과정에서 환자와 사용자 간의 교차 오염을 방지하기

Single-use medical examination gloves-Part 2:Specification for gloves made from poly(vinyl chloride)

KS P 6001-2009 玻璃水银体温计

이 표준은 사람 및 동물의 체온을 측정하기 위하여 일반적으로 사용하고 있는 유리제 수은 체

Clinical thermometers(Mercury-in-glass, with maximum device)

KS P 6012-2009 非血管式电子血压计

이 표준은 박대(cuff)에 의한 상완(上腕) 가압기구를 가지고 코로토코프(korotoko

Noninvasive electronic sphygmomanometers

KS P 6002-2009 电子体温计

이 표준은 사람의 체온 검출에 전기식 온도 검출기를 사용한 최고 온도유지 기구붙이로서 내부

Clinical electrical thermometers with maximum device

KS P 6011-2009 血压计

이 표준은 혈압계에 대하여 규정한다. 다만, 전기식인 것을 제외한다.

Sphygmomanometer

KS P ISO 5364:2009 麻醉和呼吸设备.口咽部导气管

이 표준은 플라스틱 재료 및/또는 금속으로 만들어 삽입한 보강재를 포함한 플라스틱 재료 및

Anaesthetic and respiratory equipment－Oropharyngeal airways

KS P 3506-2009 消毒盘

이 표준은 의과에서 사용하는 소독쟁반에 대하여 규정한다.

Sterilizing trays

KS P 2009-2009 医用镊

이 표준은 의료용 겸자(이하 겸자라 한다.)에 대하여 규정한다.

Medical forceps

KS P 2008-2009 医用敷料镊

이 표준은 병행식 스폿 용접형 의료용 퍼셉(이하 퍼셉이라 한다.)에 대하여 규정한다.

Medical dressing forceps

KS P 2619-2009 泪腺针探

이 표준은 안과에서 사용하는 누관 소식자(이하, 소식자라 한다.)에 대하여 규정한다.

Lacrimal probe

KS P 4404-2009 太阳眼镜镜片

이 표준은 눈, 높은 산, 해안, 수면, 하늘, 기타 일반 옥외에서의 강렬한 태양광선에 대

Lenses for sunglass

DIN 61632:2009 外科绷带.棉绉纱绷带

Surgical dressings - Cotton crepe bandages

BS EN 455-2:2009 一次性医疗用手套.物理性能要求和试验

This European Standard specifies requirements and gives test methods for physical properties of singleuse medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Medical gloves for single use - Requirements and testing for physical properties

BS EN 455-2:2009+A1:2011 一次性医用手套.物理性质的要求和测定

Medical gloves for single use. Requirements and testing for physical properties

BS EN ISO 10555-1:2009 一次性使用无菌血管内导管.一般要求

Sterile, single-use intravascular catheters - General requirements

DIN EN 455-4:2009 一次性医用手套.第4部分:货架寿命测定的要求和试验,德文版本EN 455-4:2009

This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination; English version of DIN EN 455-4:2009-10

DIN EN ISO 14408:2009 激光手术用气管导管.标记和伴随信息的要求(ISO 14408-2005); 德文版本 EN ISO 14408-2009

This International Standard specifies marking, labelling and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser.

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005);English version of DIN EN ISO 14408:2009-08