1、 IEC 60987 Edition 2.0 2013-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Nuclear power plants Instrumentation and control important to safety Hardware design requirements for computer-based systems Centrales nuclaires de puissance Instrumentation et contrle-commande importants pour la sret Exigenc
2、es applicables la conception du matriel des systmes informatiss IEC60987:2007/A1:2013AMENDMENT 1 AMENDEMENT 1 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in
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16、si vous avez des questions contactez-nous: csciec.ch. IEC 60987 Edition 2.0 2013-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Nuclear power plants Instrumentation and control important to safety Hardware design requirements for computer-based systems Centrales nuclaires de puissance Instrumentatio
17、n et contrle-commande importants pour la sret Exigences applicables la conception du matriel des systmes informatiss INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE J ICS 27.120.20 PRICE CODE CODE PRIX ISBN 978-2-83220-626-3 AMENDMENT 1 AMENDEMENT 1 Registered tr
18、ademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr
19、. 2 60987 Amend. 1 IEC:2013 FOREWORD This amendment has been prepared by subcommittee 45A: Instrumentation and control of nuclear facilities, of IEC technical committee 45: Nuclear instrumentation. The text of this amendment is based on the following documents: FDIS Report on voting 45A/897/FDIS 45A
20、/906/RVD Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. The committee has decided that the contents of this amendment and the base publication will remain unchanged until the stability date indicated on the IEC web
21、 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 At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. _ 2 Normative references Add the following standards: IEC 62671, Nuclear power plants Instrumentation and cont
22、rol important to safety Selection and use of industrial digital devices of limited functionality ISO 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 2768-2, General tolerances Part 2: Geometrical tolerances for features wit
23、hout individual tolerance indications ISO 3951-1, Sampling procedures for inspection by variables Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL ISO 3951-2, Sampling procedures f
24、or inspection by variables Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics 9 Manufacturing Replace the existing text with the following new text: 9.1 Quality assurance 9.1.1 Manufacturi
25、ng may be one phase of the overall safety life cycle (see 4.1 and 4.2). 60987 Amend. 1 IEC:2013 3 Where manufacturing is a phase of the overall safety lifecycle then manufacturing activities shall be included in the hardware quality assurance plan of the overall safety life cycle or, if not, shall b
26、e addressed by a separate manufacturing quality assurance plan (see 4.3). Manufacturing-related activities during the design process (such as manufacturing assessments during product qualification) shall be included in the hardware quality assurance plan of the overall safety life cycle. Hardware pr
27、oduced during the manufacturing phase, and addressed in this clause, includes individual modules, sub-assemblies or equipment as a whole. 9.1.2 The primary consideration when defining manufacturing processes to which the quality assurance plan applies shall be to ensure that the manufacturing does n
28、ot compromise the delivery of the safety functions by the product. 9.1.3 Procedures and work instructions shall be established for the manufacturing activities. These activities include manufacturing processes and their control, inspection and testing, independent quality surveillance and inspection
29、, identification, handling, packaging, storage and delivery. 9.1.4 The extent and details of procedures and work instructions necessary for manufacturing activities shall be defined according to the relative importance of the safety functions being performed by the hardware components (the intended
30、system Class). The objectives of the manufacturing activity are: to ensure the manufactured items are identical and meet the product description and specification generated during the design and development phases, to ensure the production items meet the requirements demonstrated by the initial mode
31、l during the qualification programme. 9.1.5 When the hardware contains components provided by external suppliers, the suppliers shall be evaluated and selected based on their ability to manufacture and supply these items in accordance with the design requirements, including the requirements in Claus
32、e 9 and appropriate quality assurance program requirements. In the case where a programmable electronic equipment component is part of the external scope of supply, an assessment of the suppliers ability and willingness to support a successful qualification of the equipment should be performed as pa
33、rt of supplier qualification. NOTE Specific product selection and qualification criteria may be found, as appropriate, in standards such as IEC 60880, IEC 61513 or in related sub-tier standards such as IEC 62671 and IEC 62566. 9.1.6 When the designer of the I any requirements for the customer approv
34、al of changes during manufacture to the sourcing of components or manufacturing consumables (e.g. solder); any requirements for the customer approval of the substitution during manufacture of components or manufacturing consumables (e.g. solder); any special training as a consequence of the equipmen
35、t having a nuclear application. 9.4.2 Any requirements specified during the design process which have an impact on the manufacturing process shall be taken into account. This includes any statutory or regulatory requirements applicable to the product as well as physical and technical characteristics
36、. NOTE Commonly used manufacturing standards may be considered based on the safety Class of the functions being performed by the hardware components. (e.g. ISO and ISA manufacturing standards, NEMA enclosures and protections standards, fire ratings standards, material processes standards, wiring tec
37、hniques standards, etc.). 9.4.3 Input documents shall be reviewed prior to initiating purchasing activities and manufacturing activities. The review shall ensure that product requirements are defined and that the defined requirements can be met. The findings of the review shall be recorded. 60987 Am
38、end. 1 IEC:2013 5 9.5 Purchasing and procurement 9.5.1 Purchasing and procurement process 9.5.1.1 Specific purchase requirements shall be established based upon the effect of the purchased product on subsequent product realization or the final product. The requirement shall include a list of documen
39、ts or access to documents necessary to achieve the qualification of the equipment. 9.5.2 Procurement process of commercially available components 9.5.2.1 Adequate demonstration or other suitable evidence shall be provided, that all the equipment components, including electronic components boards and
40、 housings meet the specified requirements (e.g. functionality, environmental withstand, reliability and lifetime). 9.5.2.2 Demonstration shall be provided that the selected components fulfil the expected characteristics. The demonstration may be based on: data provided by the supplier of the compone
41、nts (nature and results of testing after manufacture, feedback, results of periodic tests, audits, approvals know-how, etc.), or self-established, formalized and documented feedback obtained through checks performed on successive batches, results of periodic tests conducted on samples, and operating
42、 results (such as operating time, failures of components), analysis (e.g. circuit level FMEA), component level operating history assessment, design quality assurance process and records, previous product/component certifications or qualifications, or results obtained during type test previously perf
43、ormed. 9.5.2.3 Adequate means shall be established to demonstrate the quality of the purchased component. This quality demonstration shall be commensurate with the safety Class of the intended function(s) of the component(s). NOTE 1 Related means can consist of type tests of the component itself or
44、of a sub-assembly including it. NOTE 2 The expected quality includes the physical behaviour, static and dynamic electrical behaviour, under normal and extreme environmental conditions as well as the expected reliability. For programmable electronic equipment, refer to specific product selection and
45、qualification criteria in IEC 60880 and IEC 61513 and its related sub-tier standards such as IEC 62671, or IEC 62566 as appropriate. 9.5.3 Procurement process of parts used in the I be adjusted or re-adjusted when necessary; have identification in order to determine their calibration status; be safe
46、guarded from adjustments that would invalidate the measurement result; be protected from damage and deterioration during handling, maintenance and storage. 9.6.5.5 Quality assurance processes shall ensure that if manufactured equipment is found not to conform to requirements due to faults in the man
47、ufacturing process that adequate corrective action is taken. 9.6.5.6 Records of the results of calibration and verification shall be maintained. 9.6.5.7 When software based devices are used in the monitoring and measurement activities, the ability of the device to satisfy the intended application sh
48、all be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. 9.6.6 Ide
49、ntification and traceability 9.6.6.1 The manufactured system shall be identified, as well as the parts and materials used to manufacture the system, by suitable means throughout product realization. 9.6.6.2 The manufactured system status shall be monitored throughout the overall production process. 9.6.6.3 A unique identification of the system, and of the included parts, shall be ensured and records of change
