IEC 60987:2007/AMD1:2013
(Amendment)Amendment 1 - Nuclear power plants - Instrumentation and control important to safety - Hardware design requirements for computer-based systems
Amendment 1 - Nuclear power plants - Instrumentation and control important to safety - Hardware design requirements for computer-based systems
This second, updated edition deals with electrical, thermal and loading characteristics of rotating anode X-ray tubes and X-ray tube assemblies intended for use in medical diagnosis, concerning their behaviour during and after energization.
Amendement 1 - Centrales nucléaires de puissance - Instrumentation et contrôle-commande importants pour la sûreté - Exigences applicables à la conception du matériel des systèmes informatisés
Traite des caractéristiques électriques, thermiques et de charge des tubes radiogènes à anode tournante et des gaines équipées prévus pour l'utilisation dans le diagnostic médical concernant leur comportement pendant et après la mise sous tension.
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IEC 60987 ®
Edition 2.0 2013-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Nuclear power plants – Instrumentation and control important to safety –
Hardware design requirements for computer-based systems
Centrales nucléaires de puissance – Instrumentation et contrôle-commande
importants pour la sûreté – Exigences applicables à la conception du matériel
des systèmes informatisés
IEC 60987:2007/A1:2013
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IEC 60987 ®
Edition 2.0 2013-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Nuclear power plants – Instrumentation and control important to safety –
Hardware design requirements for computer-based systems
Centrales nucléaires de puissance – Instrumentation et contrôle-commande
importants pour la sûreté – Exigences applicables à la conception du matériel
des systèmes informatisés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX J
ICS 27.120.20 ISBN 978-2-83220-626-3
– 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/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 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 control 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 without
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 for 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 Manufacturing 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 be 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 produced 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 not 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, 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 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 model
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 Clause 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 supplier's ability and willingness to support a
successful qualification of the equipment should be performed as part 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&C system chooses to outsource any process that affects
product conformity to requirements, control over such processes shall be ensured. The type
and extent of control to be applied to these outsourced processes shall be defined within the
quality management plan.
9.1.7 Criteria for the selection, evaluation and re-evaluation of either external suppliers or
sub-contractors shall be established (e.g. general information such as business areas, scope
of supply, technical capability and manufacturing capacity, quality organization, system and
technical audits, financial health, market behaviour, etc.).
9.1.8 Criteria for selection, evaluation and re-evaluation of external products shall be
established and these criteria shall be based on the requirements of relevant standards (e.g.
IEC 60880, IEC 62671 and/or IEC 62566).
– 4 – 60987 Amend. 1 © IEC:2013
9.1.9 The use of manufacturing processes independently certified to recognised international
standards by accredited bodies is recommended (e.g. the International Register for
Certificated Assessors scheme for ISO 9001).
9.2 Training of personnel
9.2.1 The necessary competence for personnel performing any kind of work involved in the
manufacturing and control activities shall be established, documented and maintained.
9.2.2 If personnel experience, education, and training records do not by themselves fulfil the
requirements of 9.2.1, training or relevant other actions shall be provided to achieve the
necessary competence. The effectiveness of the training and actions taken shall be evaluated
and recorded.
9.2.3 The personnel shall be trained to be aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality and safety objectives. In
addition, appropriate records of education, training, skills and experience shall be established
and maintained.
9.3 Planning and organisation of the manufacturing activities.
9.3.1 As part of the overall project planning (see 4.3), a manufacturing plan shall be
established at the start of the project and shall be kept up to date throughout the project.
9.3.2 Interfaces between different groups involved in the design and development shall be
managed to ensure effective communication, clear definition of and assignment of
responsibility for all aspects of the equipment relevant to the manufacturing process.
9.3.3 Effective arrangements for communicating with customers or inspectors shall be
established to define and schedule manufacturing steps and the associated inspections,
audits or controls.
9.4 Input data
9.4.1 Manufacturing inputs shall be established during the design and development phase in
order to provide appropriate information for purchasing, production and quality controls
including product acceptance criteria.
The input data shall include the following information:
– the need for independence between manufacturing activities and the associated
processes documented formally;
– any requirements for the customer approval 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 equipment 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.
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 techniques 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 Amend. 1 ©
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