1、- STDeBSI BS EN 12740-ENGL 1999 = Lb24bb9 0813011 789 E BRITISH STANDARD Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste The European Standard EN 127401999 has the status of a British Standard ICs 07.080; 07.100.01 NO COP
2、YING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPRIGH LAW BS EN 12740: 1999 BS EN 12740:1999 been prepared under the Committee for Materiais and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 direction of the Sector Amd. No. Dat
3、e O BSI 11-1999 National foreword Comments This British Standard is the English language version of EN 127401999. The UK participation in its preparation was entrusted to Technical Committee CIE%, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - present to th
4、e responsible European committee any enquiries on the - monitor related international and European developments and promulgate interpretation, or proposals for change, and keep the K interests informed them in the UK A list of organizations represented on this committee can be obtained on request to
5、 its secretary. Cross-references The British Standards which implement international or European publications referred to in thii document may be found in the BSI Standards Caalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI
6、Standards Electronic Catalogue. A British Standard does not purport to include all the nececsary 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 o
7、f pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 11 and a back cover. was last issued. - The BSI copyright notice displayed in this document indica 07.100.01; 13.030.30 Enghsh version Biotechnology- Laboratories for research, development and analysi
8、s- Guidance for han-, inactivabng and testin$ of waste Biotechnologie - Labomtoires de recherche, dveloppement etyanaiyse - Guide pour la manipulation, linactivation et le contrle des dchets Abfllen Biotechnik - Liboratmien fr Forschung, Fhtwickiung und Analyse - IiWen fr die Behandlung, Inaktivieru
9、ng und pnifung von 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 this European Standard the status of a national standard without any alteration. Upto-date lists and bibl
10、iographical references concerning such nationai standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three officiai versions (English, French, Gem). A version in any other language made by translation under the responsibility of a
11、 CEN member into its own language and notifed to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Fnland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway
12、, Portugal, Spain, Sweden, Switzerland and United Kingdom. European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1060 Brussels O 1999 CEN All rights of exploitation in any form and by any means reserved worldwi
13、de for CEN national Members. Ref. No. EN 127401999 E STD-BSI BS EN 32740-ENGL L999 Lb24669 0833034 478 = Page 2 EN 12740:1999 Foreword This European Standard has been prepared by Technical Committee CENflC 233 Biotechnology, the Secretariat of which is held by AFNOR. This European Standard shad be g
14、iven 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 shail be withdrawn at the latest by January 2000. According to the CENKENELEC internal Regulations, the national standards organizat
15、ions of the foilowing countries are bound to implement this European Standard Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, I*, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This European Standard has be
16、en prepared under a mandate given to CEN by the European Commission and the European Free Me Association. Contents Foreword Introduction 1 2 3 4 5 6 7 8 9 10 11 12 Scope Normative references Definitions Waste management Segregation of waste Waste containen Waste collection Storage of waste Selection
17、 of treaiment methods Disposal mehods Ming and validation of waste treatment methods Risk management Annex A (iormative) Considerations for waste containers Annex B (informative) Bibliography Page 2 3 3 3 3 4 5 5 5 6 6 8 8 9 10 11 O BSI 11-1999 Introduction Compliance with this European Standard wil
18、 minimize the risks associated with the collection, storage, packaging, inra-iaboratory transport, treatsnent and disposal of waste including effluent and those arisii from the treatment for reuse or recyciing of contaminated items, equipment and materialc. This European Standard aims to harmonize t
19、he treatment of waste containing hazardous organisms. More extensive national and international legislative provisions should be observed. The principles for iaboratories established in this European Standard are consistent with those relevant to large scale biotechnology processes. The presence of
20、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 i, 2) RgUhhOnS. 1 scope This European Standard gives guidance on methods for handling, inactivating and testing of waste containing
21、 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 activities which contains organisms hazardous or potentidy hazardous to humans, animais, plants or the environment.
22、 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 contaminated with organisms. Wastes may be generated by biotechnology, ciinid, molecular biology, microbiology and other laborat
23、ories in activities where organisms are handled, genetically modified organisms are created or used or by laboratory processes involving materiai of human, animai or piant origin. This European Standard does not apply to other types of waste or waste from hm heaithcare or other medical treatment act
24、ivities. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are iisted hereafter. For dated references, subsequent amendments to
25、 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 the publication referred to applies. EN 285, Sterilization - Steam strixers - Large sterilizers. EN 8 c) methods for the segr
26、egation of other categories of waste (such as hazardous chemical or radioactive products) which do not contain organismC when there is incompatibility with the biohazardow waste treatment methods. NOTE 1 hazardous materials (e.g. toxic chemicals and radioactive substances) should need special attent
27、ion. For example, for biological and radioactive waste the risk to be first treated should be determined by risk assessment. NOTE 2 in cases of small quantities of waste and in laboratories of containment level 3 or 4, segregation may not be useful. Segregation methods or procedures including design
28、ated containers for the waste should facilitate differentiation and identification of the wastes streams and prevent the inadvertent mixing of the various types. NOTE 3 Hazardous and non-hazardous wastes which do not contain organisms wili generally be subject to other European or national legal con
29、trols and should be handled accordingly. NOTE 4 Segregation of wastes at the point of generation can reduce the risk of exposure of waste handlers to organisms and by preventing the contamination of other wastes by such agents reduce the btal quantity of biohazardous waste generated by the laborator
30、y. Combination wastes containing biological and other 6 Waste containers Containers used for the collection of biohazardous waste in the laboratory should be selected after consideration of the following factors and, where appropriate, specing validated methos for decontaminah g containers: a) the n
31、ature of be waste as a liquid, slw, solid or a sharp; b) the handling and transportation methods and procedures; c) the treatment methods for the waste; d) the decontamination of the container for reuse; e) the means of identifying different wastes; f) the abii to provide the necessary degree of phy
32、sical containment. Adequate supplies of containers should be provided so that the waste can be discarded immediately int an appropriate container to eliminate subsequent sorting, repackaging and other handling operations. NOTE 1 Considerations relating to containers for sharps, liquid and solid wast
33、e are given in annex A. Page 6 EN 12744k1999 Suitable means should be provided to identify containers for Merent waste types, for example by colour coding, permanent and legible wording or securely ked and clearly worded labels. In the case of reusable containers, the colour coding or labels should
34、be unaffected by any decontamination process. The container or its label should be marked with the international biohazard sign, unless it is used only for waste from containment level 1. There should be an effective closure device or means for sealing the contajner so as to maintain containment dur
35、ing subsequent handling. NOTE 2 Closure devices include, for example, integral closure devices, plastics or wire ties, and thermal sealing devices. Containers should be made of a material which is permeable to the sterilant if the contents are to be sterilized with steam or gaseous fumigant or const
36、ructed in such a way that the sterilant is able to penetrate the load. Biohazardous waste containers should not be used for other waste items, materials or substances. NOTE 3 Containers for laboratory waste should conform to national regulations with regard colour coding, materials of construction,
37、shape and size. in particular, waste containers which are used for off-site transportation should be constructed and labelled in accordance with the European Agreement on the international Carriage of Dangerous Goods by Road (ADR). 7 Waste collection 7.1 General requirements Waste should be inactiva
38、ted or rendered safe before fmal disposal or discharge. If treatment is not undertaken within the laboratory the waste should be conveyed in sealed robust containers to a separate treatment area and in accordance with any packaging and tsansport requirements for off-site conveyance. Waste containers
39、 should be removed from the laboratory when their safe capacity has been reached or at periodic intervals and transported to a storage or holding area pending treatment or disposal. An external decontamination of containers should be carried out according to the level of risk. 7.2 Waste conveyance a
40、nd transport Wheeled appliances used for the collection and on-site transportation of waste containers should be designed and constructed so as to: a) enable the containers to be easily loaded, secured and unioaded; b) prevent damage to the containers from rough or sharp surfaces or from sharp protu
41、berances which may puncture the containers; c) be easily cleaned and decontaminated; d) be easily moved and manoeuvred. O BSI 11-1999 Page 6 EN 1274k1999 r Treatment 8 Storage of waste Type of waste Storage should apply only to waste from containment levels 1 and 2 awaiting off-site conveyance for t
42、reatment and disposai. Waste containment from level 3 may exceptionally be stored for a short period of the if an autoclave is not immediately accessible. The design, constsuction and facility requirements for a biohazardous waste store and according to the level of risk, should be such that: a) the
43、 store is a clearly designated area separated from the work space; b) the store is separated away from delivery or storage areas for in-coming goods and from any areas used for food storage, preparation or consumption; c) where appropriate, access to the store is such that waste collection appliance
44、s can be wheeled inside for unloading and that vehicles can safely and conveniently approach to remove waste for off-site treatment and disposal; d) the methods and materials used in the construction enable the store to be easily cleaned and decontaminated; e) where appropriate, the store should be
45、physically secure to prevent access by unauthorized persons and to prevent entry by animals and infestation by insects or rodents; f) at containment level 2 and higher, the store for biohazardous waste is marked with the international biohazard symbol and has a clearly printed and permanent sign dis
46、played at the enw. NOTE Where only small quantities of waste are generated by the laboratory it may be inappropriate to provide a separate store or storage area. In such cases a suitable and clearly defined area of the laboratory should be designated for waste storage and heavyduty rigid containers
47、provided to accommodate the waste. Alternatively, refrigerators or freezers within the laboratory may be reserved for waste storage. Thermal 9 Selection of treatment methods 9.1 General Biohazardous waste should, if required, be inactivated or rendered safe before final disposal or discharge. The de
48、cision to treat biohazardous waste and choice of treatment method should be determined in accordance with the following considerations: a) the type and nature of the waste material, b) the hazard of the organisms in the waste; c) the efficiency of the treatment method; d) the operating conditions of
49、 the treatment method. The trealment method should be amenable to validation, should be independent of any packaging and should be monitored NOTE Monitoring can involve sampling and analysis or testing of the effluent for hazardous organisms or the use of suitable physical engineering or other process controls to demonstrate effective operation within the prescribed operating criteria. nealment of the waste should be validated with regard to the inactivation of the organisms and the inactivation of any residual contamination of the packaging or containers. GaS L
