1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12740:1999 The Euro
2、pean Standard EN 12740:1999 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Laboratories for research, development and analysis Guidance for handling, inactivating and testing of wasteThis British Standar
3、d, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 BSI 11-1999 ISBN 0 580 32818 X BS EN 12740:1999 Amendments issued since publication Amd. No. Date Co
4、mments National foreword This British Standard is the English language version of EN 12740:1999. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible Europ
5、ean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cr
6、oss-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electro
7、nic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This docu
8、ment comprises a front cover, an inside front cover, the EN title page, pages 2 to 11 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee f
9、u r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12740:1999 E EUROPEAN STANDARD EN 12740 NORME EUROPE ENNE EUROPA ISCHE NORM July 1999 ICS 07.080; 07.100.01;
10、13.030.30 English version Biotechnology Laboratories for research, development and analysis Guidance for handling, inactivating and testing of waste Biotechnologie Laboratoires de recherche, de veloppement etyanalyse Guide pour la manipulation, linactivation et le contro le des de chets Biotechnik L
11、aboratorien fu r Forschung, Entwicklung und Analyse Leitfaden fu r die Behandlung, Inaktivierung und Pru fung von Abfa llen This European Standard was approved by CEN on 14 June 1999. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
12、this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions
13、 (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czec
14、h Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12740:1999 BSI 11-1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233 Biotechnology,
15、 the Secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2000, and conflicting national standards shall be withdrawn at the latest by January 2000. Accor
16、ding to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal
17、, Spain, Sweden, Switzerland and the United Kingdom. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Waste management
18、 4 5 Segregation of waste 5 6 Waste containers 5 7 Waste collection 5 8 Storage of waste 6 9 Selection of treatment methods 6 10 Disposal methods 8 11 Testing and validation of waste treatment methods 8 12 Risk management 9 Annex A (informative) Considerations for waste containers 10 Annex B (inform
19、ative) Bibliography 11Page 3 EN 12740:1999 BSI 11-1999 Introduction Compliance with this European Standard will minimize the risks associated with the collection, storage, packaging, intra-laboratory transport, treatment and disposal of waste including effluent and those arising from the treatment f
20、or re-use or recycling of contaminated items, equipment and materials. This European Standard aims to harmonize the treatment of waste containing hazardous organisms. More extensive national and international legislative provisions should be observed. The principles for laboratories established in t
21、his European Standard are consistent with those relevant to large scale biotechnology processes. The presence of hazardous organisms among the waste and the way in which it is handled should be determined by risk assessment in accordance with the national and European (see annex B l, 2) regulations.
22、 1 Scope This European Standard gives guidance on methods for handling, inactivating and testing of waste containing organisms arising from biotechnology laboratory activities and processes. It is concerned with methods to reduce the risks arising from exposure to waste derived from laboratory-scale
23、 activities which contains organisms hazardous or potentially hazardous to humans, animals, plants or the environment. Such waste may include organisms whether as solid, liquid or gaseous by-products or effluent, together with items or equipment required to be disposed of and which may be contaminat
24、ed with organisms. Wastes may be generated by biotechnology, clinical, molecular biology, microbiology and other laboratories in activities where organisms are handled, genetically modified organisms are created or used or by laboratory processes involving material of human, animal or plant origin.
25、This European Standard does not apply to other types of waste or waste from human healthcare or other medical treatment activities. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at t
26、he appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of th
27、e publication referred to applies. EN 285, Sterilization Steam sterilizers Large sterilizers. EN 866-1, Biological systems for testing sterilizers and sterilization processes Part 1: General requirements. EN 12128, Biotechnology Laboratories for research, development and analysis Containment levels
28、of microbiology laboratories, areas of risk, localities and physical safety requirements. EN 61010-2-041, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials and
29、 for laboratory processes. IEC 61010-2-041:1996 EN 12347, Biotechnology Performance criteria for steam sterilizers and autoclaves. 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 biohazardous waste biological waste which can cause a hazard 3.2 decontamination re
30、moval of microbiological contamination or reduction to an acceptable level 3.3 disinfectant chemical agent which is able to reduce the number of viable microorganisms 3.4 disinfection process of reducing the number of viable microorganisms by various physical and chemical methods 3.5 disposal intent
31、ional and final burial, deposit, discharge, dumping, placing or release of any waste material into or on any air, land or water 3.6 hazard intrinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTE Harm is an injury or damage to h
32、ealth of people and/or to the environment. 3.7 inactivation partial or full destruction of a given activity up to destruction of the microbiological systemPage 4 EN 12740:1999 BSI 11-1999 3.8 microorganism any microbiological entity, cellular or non cellular, capable of replication or of transferrin
33、g genetic material EN 1619 NOTE For the purposes of this standard, the term microorganism covers the term of biological agent, according to the Directive 90/679/EEC: microorganisms, including those which have been genetically modified, cell cultures and human endoparasites which may be able to provo
34、ke any infection, allergy or toxicity. 3.9 monitoring regular or continuous observation or collection of data with respect to an organism, process or procedures 3.10 organism biological entity capable of replication or transferring genetic material 3.11 risk probability of occurrence of a hazard cau
35、sing harm and the degree of severity of the harm 3.12 sharps items whether intact or broken which may cause lacerations or puncture wounds NOTE Examples of sharps are hypodermic needles, disposable blades, forceps, knives, probes, scalpels and scissors, glass pipettes, slides and cover glasses, brok
36、en glass or plastic ware. 3.13 sterile state of being free from viable microorganisms NOTE 1 In practice no such absolute statement regarding the absence of viable microorganisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method of st
37、erilization. NOTE 2 The process of inactivation of viable microorganisms during a sterilization procedure is usually described by an empirical mathematical function, commonly an exponential function. By their mathematical nature, such functions can be reduced to very low numbers, but not to zero. Ho
38、wever, these empirical functions can be applied to control or assess the process parameters of a sterilization procedure to realize a desired degree of inactivation of viable microorganisms. 3.14 sterilization process used to reach a sterile state 3.15 validation documented procedure for obtaining,
39、recording and interpreting the results needed to show that a process will constantly yield a product complying with predetermined specifications 3.16 waste by-product arising from a process or unwanted substance or article derived from any activity NOTE Examples of waste are scrap material, effluent
40、, unwanted residue or surplus arising from any process or activity or any substance or article which is discarded or to be disposed of as being broken, contaminated, spoiled, or worn out. 4 Waste management A documented waste management policy should be established describing the measures for the pr
41、evention, minimization, segregation, handling, storage, treatment, transportation and final disposal of biohazardous waste from laboratory activities. The policy should commit the laboratory to minimize the production of waste and where possible the recovery of materials. The waste management system
42、 should be part of the overall risk assessment of the laboratorys activities. This should assure that it is appropriate to the work carried out and the wastes generated. The waste management policy and system and the responsibilities and duties allocated to laboratory managers, researchers and techn
43、ical personnel should be specified in a waste management plan. The arrangements for effective control of biohazardous waste should be integral with the general management and supervisory organization. Documented operational procedures describing the methods used for effective waste management should
44、 be established. These documents should be reviewed at regular intervals and updated if necessary. A description should be given of the methods and procedures for handling, inactivating and treating biohazardous waste under both normal conditions and deviations. Procedures should also be described f
45、or the commissioning, maintenance and use of plant and equipment used for waste treatment in accordance with appropriate European Standards and guidelines. Comprehensive information should be provided on the risks to human health and safety and to the environment arising from waste which contains or
46、ganisms together with details of its treatment and the prevention and control measures used in normal procedures and in emergencies. This information should be understandable to technical and non-technical personnel alike. The quality of the waste management system should be assured by periodic moni
47、toring of the various arrangements and procedures. These include operating conditions and control devices of laboratories and equipment, the composition and characterization of the waste loads and adherence to approved standard operating procedures. Test and inspection results should be documented t
48、ogether with details of any action taken to correct deviations from the intended operating conditions.Page 5 EN 12740:1999 BSI 11-1999 5 Segregation of waste The following essential elements with regard to the segregation of waste should be considered during risk assessment of the laboratorys activi
49、ties and should be included and documented: a) identification of wastes which need different treatment methods; b) methods for the segregation of biohazardous from non-biohazardous waste at the point of origin, if possible; c) methods for the segregation of other categories of waste (such as hazardous chemical or radioactive products) which do not contain organisms when there is incompatibility with the biohazardous waste treatment methods. NOTE 1 Combination wastes containing biological and other hazardous ma
