11.080 消毒和灭菌 标准查询与下载

LST EN 1276-1999 化学消毒剂和防腐剂 用于食品、工业、家庭和机构领域的化学消毒剂和防腐剂杀菌活性评价的定量悬浮试验 试验方法和要求（第 2 阶段）

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas - Test method and requirements (phase 2

CAN/CSA-Z11140-1-1998(R2004) 保健品灭菌化学指标 第1部分：一般要求

This National Standard of Canada is based on International Standard ISO 11140-1:1995. 1 Scope This part of ISO 11140 specifies performance requirements for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances. NOTE 1 These indicators are used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment. This part of ISO 11140 also includes acceptance criteria used to establish whether or not an indicator complies with it. NOTE 2 Relevant test methods and equipment are described in ISO 11140-2. NOTE 3 Additional requirements for (Class 2) penetration test indicators are given in ISO 11140-3 and ISO 11140-4.

Sterilization of health care products - Chemical indicators - Part 1: General requirements

CAN/CSA-Z11140-1-1998(C2004) 保健品灭菌化学指标 第1部分：一般要求

La présente norme nationale du Canada est basée sur la norme internationale ISO 11140-1:1995. 1 Domaine d'application La présente partie de l'ISO 11140 fixe les prescriptions de performances relatives aux indicateurs exposés à des processus de stérilisation par modification des substances de nature physique et/ou chimique. NOTE 1 Ces indicateurs permettent de surveiller la présence ou l'acquisition d'un ou plusieurs paramètres requis pour satisfaire à un processus de stérilisation; ils sont également utilisés lors d'essais spécifiques du matériel de stérilisation. La présente partie de l'ISO 11140 comporte aussi des critères d'acceptation permettant de déterminer si un indicateur est conforme. NOTE 2 Les méthodes d'essai et les équipements correspondants sont décrits dans l'ISO 11140-2. NOTE 3 Des prescriptions supplémentaires concernant les indic ateurs d'essai de pénétration (classe 2) sont indiquées dans l'ISO 11140-3 et l'ISO 11140-4.

Sterilization of health products - Chemical indicators - Part 1: General requirements

ISO 11140-1:1995/Amd 1:1998 医疗保健产品灭菌 化学指示物 第1部分:通则:修改1

Sterilization of health care products - Chemical indicators - Part 1: General requirements; Amendment 1

DIN 58955-3:1998 除污设备.医学领域用的设备.第3部分:有效性试验

The document applies to the efficiency testing of decontaminations equipment used for the mechanical cleaning and disinfection of goods in the medical field. These goods primarily include bedsteads with accessories, bedside tables, transport trolleys and containers used e.g. for pharmaceuticals, medical devices, sterile goods, food, textiles and waste. Decontamination equipment can also be for operating theatre shoes and similar products.

Decontamination equipment for medical use - Part 3: Efficiency testing

CAN/CSA-ISO 11135-1998(R2003) 医疗器械 环氧乙烷灭菌的验证和常规控制

This National Standard of Canada is equivalent to International Standard ISO 11135:1994. 1 Scope 1.1 This International Standard establishes requirements and guidance for validation and routine control of ethylene oxide sterilization processes for medical devices. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the requirements of 4.2, which may be necessary for a specific product. NOTE 2 Although this International Standard has been written for medical device sterilization, it may also apply to other health care products. 1.2 It does not cover the quality assurance system which is essential to control all stages of manufacture which include the sterilization process. 1.3 It does not cover operator safety (for further information, see IEc 1010-2). Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used. Attention is drawn to the existence in some countries of statutory regulations laying down limits for the level of ethylene oxide residues within medical devices and products. 1.4 It does not cover sterilization either by the technology of injecting ethylene oxide or its mixtures directly into individual product packages or continuous sterilization processes. 1.5 It does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products (see ISO 10993-7). 1.6 It does not cover products that are affected adversely by ethylene oxide or by other ethylene oxide residuals produced in the processes described.

Medical devices - Validation and routine control of ethylene oxide sterilization

CAN/CSA-ISO 11134-1998(R2003) 保健品灭菌 验证和常规控制要求 工业湿热灭菌

This National Standard of Canada is equivalent to International Standard ISO 11134:1994. 1 Scope This International Standard specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process and control of routine sterilization. It covers all moist heat proceses, including saturated steam and air-steam mixtures, and applies to all industrial manufacturers and all others who perform contract moist heat sterilization. Although moist heat sterilization in non-industrial health care facilities is not specifically covered in this International Standard, the principles outlined may be useful to the user of moist heat sterilization in these facilities. NOTE 1 While the general requirements of this International Standard may apply to the sterilization of pharmaceuticals, other technical or regulatory requirements may also apply. This International Standard does not cover the quality assurance system which is necessary to control all stages of manufacture, including the sterilization process.

Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization

SNI 16-4942-1998 孵化器运输

Transport incubator

CAN/CGSB-2.161-1997 环境表面和医疗器械用抗菌剂的功效评估

1. SCOPE 1.1 This standard specifies criteria for assessing the efficacy of antimicrobial agents intended for use on environmental surfaces in health care facilities and premises where food is prepared, manufactured or stored, and for use on medical devices. Such agents are classified as drugs under the Food and Drugs Act and Regulations (see par. 3.1). 1.2 This standard also contains requirements for assessing the efficacy of antimicrobial agents under re-use conditions. 1.3 The testing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyone using this standard has the responsibility to consult the appropriate authorities and to establish appropriate health and safety practices in conjunction with any applicable regulatory requirements prior to its use.

Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices

EN 1499:1997 化学消毒剂和防腐剂.消毒洗手液.检验方法和要求(第2阶段/2级)

This European Standard specifies a method of testsimulating practical conditions for establishing whethera product for hygienic handwash reducesThe releaseof transient flora according toThe requirements whenused for washingThe artificially contaminated hands ofvolunteers

Chemical Disinfectants and Antiseptics - Hygienic Handwash - Test Method and Requirements (Phase 2/Step 2)

EN 867-3:1997 消毒器用非生物系统.第3部分:布维-狄(Bowie和Dick)试验B级指示器用规范

This European Standard specifies the requirements for an indicator to be used in the Bowie and Dick test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. An indicator for this purpose is a Class B indicator as described in Part 1 of this standard An indicator complying to this European Standard is to be used in combination with the standard test pack as described in EN 285. This standard does not detail requirements for the standard test pack but specifies the performance of the indicator.

Non-Biological Systems for Use in Sterilizers - Part 3: Specification for Class B Indicators for Use in the Bowie and Dick Test

ISO/TR 13409:1996 健康护理制品的灭菌.辐射灭菌.少量产品用25kGy灭菌剂量的实体化证明

Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches

SNI 16-4284-1996 移动式紫外线杀菌器

Moved type ultraviolet room sterilizers

SNI 16-4221-1996 婴恒温箱(护理)

Baby incubators (nursing)

SNI 16-3770-1995 蒸汽杀菌器

Steam sterilizers

GSO 360:1994 用于一次性皮下注射的无菌胰岛素注射器和针头

This standard specifies the requirements for sterile hypodermic syringes and needles for insulin injection in accordance with the following types (see Fig. 1): Type 1: Syringe having a 6% (Luer) male conical fitting, supplied without a needle. Type 2: Syringe having a 6% (Luer) male conical fitting, and supplied with a detached or detachable needle. Type 3: Syringe having a fitting other than a 6% (Luer) taper, supplied with a needle not intended to be detached (fixed). Type 4: Syringe with a fixed needle.

Sterile hypodermic syringes and needles for insulin injection for single use.

GSO 359:1994 一次性皮下注射用无菌胰岛素注射器和针头的测试方法

This standard is concerned with the methods of testing sterile hypodermic syringes with or without needles for single use for injection of insulin.

Methods of testing sterile hypodermic syrines and needles for insulin injection for single use.

CSA Z314.14-1993(R2002) 刚性灭菌容器的选择和使用

1.1 This standard defines essential elements for using containers (rigid sterilization containers) that are designed for use in gravity, prevacuum, and ethylene oxide sterilizers. 1.2 This standard addresses instrument sets used in rigid sterilization containers. 1.3 Inclusions This standard addresses requirements for (a) general characteristics of containers; (b) testing prior to use; (c) reprocessing of containers; (d) preparation and assembly; (e) sterilizer loading and unloading; (f) sterile storage; (g) aseptic use and presentation; (h) transport of containers; and (i) quality assurance. 1.4 This standard does not address (a) protective organization cases; (b) containers designed specifically for emergency (ie, flash) sterilization; and (c) noninstrument sets (eg, linen packs). 1.5 In this standard, the word "shall" indicates a mandatory requirement; "should" indicates a recommendation, but is not mandatory. Notes accompanying clauses provide explanatory or informative material that is not properly a part of this standard.

Selection and Use of Rigid Sterilization Containers

DIN 58953-8:1993 消毒.消毒材料供应.一次性使用的医疗消毒装置的供货、储存和搬运

Sterilization; sterile supply; delivering of sterile medical devices for single use as well as its storage and handling

CAN/CSA-Z314.10-M90-1990 用于医疗机构消毒的可重复使用纺织罩的选择、使用、维护和清洗

1.1 Cette norme définit les points essentiels de la sélection, de l'utilisation, de l'entretien et du lavage des enveloppes textiles réutilisables pour la stérilisation dans les établissements de santé. Les articles visés comprennent les textiles tissés réutilisables qui ne possèdent pas de pellicule ou de revêtement, ainsi que les pellicules et les revêtements qui sont conformes aux caractéristiques de base de l'article 4.1 lorsqu'ils sont appliqués à des textiles tissés réutilisables. 1.2 Cette norme vise à assurer, pour un produit stérilisé, une barrière biologique acceptable. 1.3 Cette norme énonce des exigences minimales relatives à la fabrication et à la tenue des enveloppes textiles réutilisables, visant à assurer que : a) l'enveloppe laisse efficacement pénétrer les agents de stérilisation dans le paquet à stériliser et en sortir ; et que b) l'enveloppe est une barrière biologique efficace. 1.4 Cette norme exclut expressément tous les autres tissus comme les blouses, les draps, les serviettes, les tentures, etc., ainsi que toute autre enveloppe conçue pour une utilisation unique. 1.5 Cette norme ne vise ni les méthodes de préstérilisation ni de poststérilisation, et n'énonce ni les exigences relatives aux opérateurs de machine ni les essais à effectuer pour indiquer la probabilité de stérilité d'un produit. Note. Pour les questions exclues par l'article 1.5, voir les normes CSA Z314.2 et Z314.3. 1.6 Les valeurs indiquées en unités SI (métriques) doivent être considérées comme étant les valeurs normalisées. Les valeurs apparaissant entre parenthèses ne sont données qu'à titre d'information. 1.7 Dans cette norme, le terme « doit/doivent » indique une exigence obligatoire. Le terme « devrait/devraient » indique une recommandation, une chose conseillée mais non obligatoire. Les remarques qui accompagnent les articles donnent des renseignements ou des explications qui ne font pas strictement partie de cette norme et qu'il est préférable de séparer du corps du texte.

Selection, use, maintenance and washing of reusable textile covers for sterilization in healthcare establishments