BS PD IEC TR 62471-3-2015 Photobiological safety of lamps and lamp systems Guidelines for the safe use of intense pulsed light source equipment on humans《灯和灯系统的光生物安全 针对人类的.pdf

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1、BSI Standards Publication Photobiological safety of lamps and lamp systems Part 3: Guidelines for the safe use of intense pulsed light source equipment on humans PD IEC/TR 62471-3:2015National foreword This Published Document is the UK implementation of IEC/TR 62471-3:2015. The UK participation in i

2、ts preparation was entrusted to Technical Com- mittee EPL/76, Optical radiation safety and laser equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. User

3、s are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 84356 3 ICS 29.140.01 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the author

4、ity of the Stand- ards Policy and Strategy Committee on 28 February 2015. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 62471-3:2015 IEC TR 62471-3 Edition 1.0 2015-01 TECHNICAL REPORT Photobiological safety of lamps and lamp systems Part 3: Guideline

5、s for the safe use of intense pulsed light source equipment on humans INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 29.140 ISBN 978-2-8322-2207-2 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor

6、. colour inside PD IEC/TR 62471-3:2015 2 IEC TR 62471-3:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope and object . 7 1.1 Scope . 7 1.2 Object . 7 2 Normative references. 7 3 Terms and definitions 7 4 Responsibility for safe working conditions 8 5 Risks from exposure to IPL optical rad

7、iation . 9 5.1 Risks to the eye 9 5.1.1 Inadvertent eye exposure . 9 5.1.2 Treatment adjacent to the eye 9 5.2 Skin burns. 9 5.3 Scars 9 5.4 Hyper/hypo-pigmentation . 10 5.5 Purpura . 10 5.6 Unrecognised malignancies or premalignant conditions on the treatment site . 10 5.7 Delicate anatomy or inapp

8、ropriate treatment sites 10 5.8 Drug-induced photosensitivity 10 5.9 Contra-indicated CLIENT conditions 10 6 Causes of risks 11 6.1 General . 11 6.2 Operator errors . 11 6.2.1 SKIN TYPE . 11 6.2.2 Failure to recognize contra-indicated CLIENT conditions or photosensitizing drug use . 11 6.2.3 Incorre

9、ct or non-use of protective eyewear . 11 6.2.4 Failure to perform patch tests adjacent to the area of treatment 11 6.2.5 Failure to maintain optical components . 11 6.2.6 Failure to use the appropriate filter . 12 6.2.7 Inappropriate or inadequate skin cooling . 12 6.2.8 Inappropriate technique 12 6

10、.3 Poor CLIENT compliance . 12 6.4 IPL OUTPUT variability from older equipment 12 6.4.1 Incorrect display of the settings 12 6.4.2 Excessive power peaks 12 6.4.3 Uneven energy distribution . 13 6.5 Risks from other potential hazards . 13 6.5.1 Airborne contaminants . 13 6.5.2 Electrical safety . 13

11、6.6 Cleansing and disinfecting . 13 7 Risk assessment . 13 8 Education and training . 14 Annex A (informative) Biological effects, SKIN TYPES 16 A.1 Optical radiation spectrum . 16 PD IEC/TR 62471-3:2015IEC TR 62471-3:2015 IEC 2015 3 A.2 Fitzpatrick skin classification . 16 A.3 Structure of the eye

12、. 16 A.4 Penetration of light in the eye 17 A.5 Structure of the skin 17 A.6 Biological effects . 19 A.6.1 General . 19 A.6.2 Ultraviolet radiation 20 A.6.3 Visible radiation . 21 A.6.4 IR-A . 21 A.6.5 IR-B . 22 A.6.6 IR-C . 22 Annex B (informative) Personal eye protection . 23 Annex C (informative)

13、 IPL technology, classification 24 Annex D (informative) Warning sign . 25 Annex E (informative) . 26 E.1 Local rules 26 E.2 Sample template . 26 Bibliography . 30 Figure A.1 Structure of the eye . 17 Figure A.2 Penetration of different wavelengths through the eye . 17 Figure A.3 The structure of th

14、e skin 18 Figure A.4 Penetration of different wavelengths through the skin. 18 Figure A.5 Absorption of skin main chromophores, log scale, arbitrary units 19 Figure D.1 Warning symbol for use with IPL equipment . 25 Table A.1 Division of the optical radiation spectrum 16 Table A.2 Fitzpatrick Classi

15、fication Skin Type Scale . 16 Table A.3 Biological effects of optical radiation to the eye and skin . 19 Table C.1 Classification of risk group (IEC 62471) 24 PD IEC/TR 62471-3:2015 4 IEC TR 62471-3:2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SY

16、STEMS Part 3: Guidelines for the safe use of intense pulsed light source equipment on humans FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IE

17、C is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS)

18、 and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with

19、 the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nea

20、rly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in tha

21、t sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committee

22、s undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide a

23、ny attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest e

24、dition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether

25、direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indisp

26、ensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical com

27、mittees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC/TR 62471-3, which is

28、a technical report, has been prepared by IEC technical committee 76: Optical radiation safety and laser equipment. PD IEC/TR 62471-3:2015IEC TR 62471-3:2015 IEC 2015 5 The text of this technical report is based on the following documents: Enquiry draft Report on voting 76/497/DTR 76/505/RVC Full inf

29、ormation on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this technical report, terms printed in SMALL CAPITALS are used as defined in Cl

30、ause 3. A list of all parts in the IEC 62471 series, published under the general title Photobiological safety of lamps and lamp systems, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IE

31、C web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. IMPORTANT The colour inside logo o

32、n the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer. PD IEC/TR 62471-3:2015 6 IEC TR 62471-3:2015 IEC 2015 INTRODUCTION This technica

33、l report describes possible adverse incidents that may occur in respect of the use of IPL devices and recommends measures to avoid them. Some of the described incidents represent serious adverse effects, ranging from cosmetically significant to physically or medically significant. Provided the IPL o

34、perator is appropriately educated and trained and the guidelines in this document are followed, the use of IPL in a cosmetic setting should be no more hazardous to the CLIENT or staff personnel than similar IPL interventions in medical settings. PD IEC/TR 62471-3:2015IEC TR 62471-3:2015 IEC 2015 7 P

35、HOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS Part 3: Guidelines for the safe use of intense pulsed light source equipment on humans 1 Scope and object 1.1 Scope This part of IEC 62471, which is a technical report, provides guidelines for the safe use of INTENSE PULSED LIGHT (IPL) source equipment

36、 in professional premises. This technical report sets out the control measures recommended for the safety of recipients of IPL treatment, staff, service, maintenance personnel and others. Engineering controls which form part of the IPL equipment or the installation are also briefly described to prov

37、ide an understanding of the general principles of protection. 1.2 Object The object of this report is to provide information which helps to protect persons from hazardous exposure to optical radiation and other associated hazards by providing guidance on how to establish safety measures and procedur

38、es. NOTE Although the manufacturers provide treatment information in their instructions for use, such information may not be exhaustive or applicable to all CLIENT treatment conditions. If IPLs are applied to patients in medical premises, the physician is deemed to be responsible for all medical asp

39、ects of the treatment including his or her decisions about questions of indication and contraindication such as found in Clauses 5 and 6. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For da

40、ted references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. None. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 CLIENT person receiving the IPL tr

41、eatment EXAMPLE Customers in beauty salons or patients in medical environments. 3.2 CONTROLLED AREA area around the IPL where the local rules apply Note 1 to entry: Generally the room where the IPL is used. PD IEC/TR 62471-3:2015 8 IEC TR 62471-3:2015 IEC 2015 3.3 INTENSE PULSED LIGHT IPL equipment,

42、 containing a flash lamp, e.g. xenon or krypton, housed in a handheld device, having an emission window with an area of several cm 2 , typically providing a filter which restricts the emission to a band in the visible and infra-red Note 1 to entry: Pulse lengths are in the order of tens of ms or les

43、s and pulse repetition rates are typically two per second or less. The IPL OUTPUT is in the order of up to 50 J/cm 2 . The wavelengths range typically from 400 nm to1 200 nm. Note 2 to entry: “IPL” may be covered by trademark rights in certain countries. Generally, users and recipients of IPL treatm

44、ent comprehend the generic meaning of “IPL” as intense pulsed light. 3.4 IPL OUTPUT radiant exposure measured at the IPL emission window, as received by the human skin in contact mode application Note 1 to entry: The IPL output is expressed in J/cm 2 . Note 2 to entry: The erroneous term “fluence” i

45、s found in some brochures or in the instructions for use. 3.5 OCULAR HAZARD DISTANCE OHD radial distance from the emission window of an IPL within which the applicable exposure limit value to the unaided and non-protected eye is exceeded 3.6 RESPONSIBLE PERSON person who is made responsible for asse

46、ssing the risks of IPLs, determining the safety measures and the local rules, either the owner/operator of the facility or a person upon appointment by the owner/operator 3.7 SKIN TYPE Fitzpatrick skin type Note 1 to entry: Refer to literature about Fitzpatrick SKIN TYPES. Note 2 to entry: SKIN TYPE

47、 varies with pigmentation and sensitivity to UV and also to visible light. Different SKIN TYPES will respond differently to light exposure. In particular, darker SKIN TYPES are more likely to develop hyperpigmentation following light exposure. 4 Responsibility for safe working conditions Generally,

48、the owner/operator or RESPONSIBLE PERSON of the facility, where IPLs are used, is deemed responsible for all decisions which are related to safety. The owner or operator of the facility may appoint another competent or knowledgeable person who then deals with safety issues on behalf of the owner or

49、operator of the facility. Hence either the owner/operator of the facility or the appointed competent person assumes responsibility for the conditions necessary to safely apply the IPL, called the RESPONSIBLE PERSON. It is recommended that the responsibilities are clearly allocated. Only one RESPONSIBLE PERSON should be appointed within a facility. All employees of the facility should know who the RESPONSIBLE PERSON is, in order to be able to consult him or her when safety issues arise. NOTE T