BS 8480-2006 Medical devices - Chairs with electrically operated support surfaces - Requirements《医疗装置 带电力驱动支持表面的椅子 要求》.pdf

1、BS 8480:2006Medical devices Chairs with electrically operated support surfaces RequirementsICS 97.140NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPublishing and copyright informationThe BSI copyright notice displayed in this document indicates when the docume

2、nt was last issued. BSI 2006ISBN 0 580 48651 6The following BSI references relate to the work on this standard:Committee reference FW/1Draft for comment 05/30140467 DCPublication historyFirst published July 2006Amendments issued since publicationAmd. no. Date Text affectedBS 8480:2006 BSI 2006 iBS 8

3、480:2006ContentsForeword iii1 Scope 12 Normative references 13 Terms and definitions 14 Requirements 2Bibliography 4List of tablesTable 1 Requirements specified in BS EN 12182 2Summary of pagesThis document comprises a front cover, an inside front cover, pages i to iv, pages 1 to 4, an inside back c

4、over and a back cover.ii BSI 2006 This page deliberately left blankBS 8480:2006 BSI 2006 iiiBS 8480:2006ForewordPublishing informationThis British Standard was published by BSI and came into effect on 31 July 2006. It was prepared by Technical Committee FW/1, Common test methods for furniture. A lis

5、t of organizations represented on this committee can be obtained on request to its secretary.Information about this documentManufacturers and importers of chairs with electrically operated support surfaces should be aware that if any part of the marketing of their products can be interpreted as clai

6、ming that a product is:“intended by the manufacturer to be used for human beings for the purpose of:treatment or alleviation of disease;treatment, alleviation of or compensation for an injury or handicap;”such chairs are considered to be medical devices and therefore subject to the provisions of EC

7、Directive 93/42 EEC (the Medical Devices Directive) 1.This British Standard is applicable to chairs that are intended by the manufacturer to be used as medical devices as defined by EC Directive 93/42 (the Medical Devices Directive) 1. However, the standard is not applicable to chairs that are inten

8、ded for use during the administration of treatment by a medical practitioner, for example dentists chairs.Manufacturers of medical devices are required by law, under the Medical Devices Regulations 2002 2, to comply with the requirements of the Medical Devices Directive, including being registered w

9、ith a regulatory body in the EU known as a “competent authority”, as being responsible for placing medical devices on the market.If a company is importing medical devices into the EU and placing them on the market, and the manufacturer, or another importer within the EU, is not registered with a com

10、petent authority as being responsible for placing medical devices on the market, that company could acquire all the responsibilities of the manufacturer under the legislation.All aspects of marketing may be considered when deciding if a product is a medical device, including point of sale claims. Ma

11、nufacturers who do not have control over claims made at the point of sale are advised to consider whether they should take legal advice regarding their position.UK manufacturers and importers of medical devices can obtain guidance from the UK competent authority, which at the time of publication of

12、this British Standard is the Medicines and Healthcare products Regulatory Agency (MHRA)1).Useful guidance on the Medical Devices Directive is available from the MHRA web site at www.mhra.gov.uk which includes guidance notes for manufacturers of Class 1 medical devices and guidance notes for the regi

13、stration of persons responsible for placing devices on the market.1)Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Tel: 020 7084 2000.iv BSI 2006BS 8480:2006Hazard warningsWARNING. This British Standard calls for the use of procedures that can b

14、e injurious to health if adequate precautions are not taken. It refers only to technical suitability and does not absolve the user from legal obligations relating to health and safety at any stage.Presentational conventionsThe provisions of this standard are presented in roman (i.e. upright) type. I

15、ts requirements are presented in sentences in which the principal auxiliary verb is “shall”.Commentary, explanation and general informative material is presented in smaller italic type, and does not constitute a normative element.Contractual and legal considerationsThis publication does not purport

16、to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS 8480:20061 ScopeThis British Standard specifies safety requirements for chairs with support surfaces the positi

17、on of which can be adjusted electrically by the seated person and/or an attendant, including reclining chairs and riser chairs. It is applicable to chairs for use by a person weighing up to 100 kg. The standard is not applicable to multiple seating units.In the text of this standard the term “chairs

18、” is used to refer to chairs with electrically operated support surfaces.This British Standard is applicable to chairs that are intended by the manufacturer to be used as medical devices as defined by EC Directive 93/42 (the Medical Devices Directive) 1.The standard is not applicable to chairs that

19、are intended for use during the administration of treatment by a medical practitioner, for example dentists chairs.NOTE Chairs with electrically operated support surfaces that are not intended by the manufacturer to be used as medical devices are specified in BS 8474.2 Normative referencesThe follow

20、ing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.BS 8474:2006, Furniture Chairs with electrically operated su

21、pport surfaces RequirementsBS EN 14971:2001, Medical devices Application of risk management to medical devicesBS EN 12182:1999, Technical aids for disabled persons General requirements and test methods3 Terms and definitionsFor the purposes of this British Standard the terms and definitions given in

22、 BS 8474:2006 and the following apply.3.1 manufacturernatural or legal person with responsibility for the design, manufacture, packaging and labelling of a chair before it is placed on the marketand/or put into service, regardless of whether these operations are carried out by that person himself or

23、 on his behalf by a third party European Council Directive 93/42 of 14 June 1993 (the Medical Devices Directive) Article 1.2 (f) Paragraph one 1 BSI 2006 1BS 8480:20064 Requirements4.1 Risk management A risk analysis shall be carried out in accordance with BS EN 14971 and shall include the hazards a

24、nd risks given in BS EN 12182:1999, 5.1, 5.2, 5.4.2, 5.5, Clause 6, 8.2.1, 9.4, Clause 10, Clause 21 and Clause 24.NOTE 1 The risk analysis should include consideration of hazards associated with the following:a) the user, who might have one or more disabilities;b) carers, who might be elderly and/o

25、r have disabilities;c) healthcare personnel, who might not have been trained in the use of the chair and who might need to operate the chair adjustments whilst treating or caring for the user;d) children, particularly young children, who might play around the chair out of the sight of the user and/o

26、r carer;e) pets, particularly those that might access the inner mechanism of the chair;f) other persons living in or visiting the users environment, who might not have been trained in the use of the chair.NOTE 2 If, at the conclusion of the overall residual risk evaluation (as specified in BS EN 149

27、71:2001, Clause 7), the manufacturer concludes that the intended benefits outweigh the residual risk, he has an obligation to ensure that appropriate warnings and safety instructions are clearly, permanently and prominently applied to the chair and associated literature.4.2 General requirements4.2.1

28、 Chairs shall conform to the requirements specified in BS EN 12182:1999 for the parameters listed in Table 1.Table 1 Requirements specified in BS EN 12182Parameter Requirement specified in BS EN 12182:1999 clauseIntended performance and technical documentation4.2Clinical evaluation 4.3Aids that can

29、be dismantled 4.4Single use fasteners 4.5Flammability 5.1Biocompatibility and toxicity 5.2Contaminants and residues 5.3Infection and microbiological contamination5.4Electromagnetic compatibility Clause 7Electrical safety 8.1Overflow, spillage, leakage and ingress of liquidsClause 9Information suppli

30、ed by the manufacturer Clause 232 BSI 2006BS 8480:20064.2.2 In addition, chairs shall conform to the requirements specified in BS 8474:2006, with the exception of the requirement for information to be supplied by the manufacturer, as specified in BS 8474:2006, Clause 9.4.3 Back-up power supplyChairs

31、 shall be fitted with an internal power source capable of operating all the electrically powered support surfaces through the full range of movement, including return to the starting position, not less than six times, in the event of failure of the electrical supply mains. BSI 2006 3BS 8480:2006Bibl

32、iography1 EUROPEAN COMMUNITIES. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Luxembourg: Office for Official Publications of the European Communities, 1993.2 GREAT BRITAIN. The Medical Devices Regulations 2002, SI 2002 No. 618 (as amended). London: The Stationery Office.4

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