SIST EN IEC 63000:2019
(Main)Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
IEC 63000:2016 specifies the technical documentation that the manufacturer compiles in order to declare compliance with the applicable substance restrictions
Technische Dokumentation zur Beurteilung von Elektro- und Elektronikgeräten hinsichtlich der Beschränkung gefährlicher Stoffe
Documentation technique pour l'évaluation des produits électriques et électroniques par rapport à la restriction des substances dangereuses
L'IEC 63000:2016 spécifie la documentation technique que le fabricant rassemble pour déclarer qu'il est en conformité avec les limitations en vigueur pour certaines substances.
Tehnična dokumentacija za presojo električnih in elektronskih naprav v zvezi z omejitvami pri nevarnih snoveh
Ta dokument določa tehnično dokumentacijo, ki jo izdelovalec pripravi, da potrdi skladnost z veljavnimi omejitvami glede snovi.
Dokumentacija sistema upravljanja izdelovalca je zunaj področja obravnave tega dokumenta.
General Information
- Status
- Published
- Publication Date
- 17-Feb-2019
- Technical Committee
- ITIV - Electronics assembly technology and Environmental standardization
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 12-Feb-2019
- Due Date
- 19-Apr-2019
- Completion Date
- 18-Feb-2019
Relations
- Effective Date
- 11-Dec-2018
Overview
EN IEC 63000:2018 (IEC 63000:2016) specifies the technical documentation that manufacturers of electrical and electronic products must compile to declare compliance with applicable restrictions on hazardous substances (e.g., RoHS). The standard defines the minimum content and process for assembling evidence that materials, parts and sub‑assemblies meet substance restrictions. It is focused on documentation of product content and supplier information; the manufacturer’s management system records are outside the scope.
Key Topics
- Purpose: Provide a structured, auditable technical file demonstrating conformity with substance‑restriction regulations.
- Required content:
- General product description and intended use (important for exemption assessment).
- Documentation for materials, parts and sub‑assemblies, including supplier declarations, material data and test reports.
- Mapping between technical documents and the corresponding items in the product (BOM‑to‑documentation traceability).
- List of standards and technical specifications referenced to establish the documentation.
- Information lifecycle (as outlined in clause 4.3):
- Identify tasks the manufacturer must perform.
- Determine the information needed from suppliers.
- Collect supplier data and test results.
- Evaluate and review the collected information for compliance.
- Normative references: the standard relies on chemical test methods and data formats such as the IEC 62321 series (determination of substances) and IEC 62474 (material declaration format).
Applications
Who uses EN IEC 63000:2018 and why:
- Manufacturers and OEMs - to compile a RoHS‑compliant technical file and to support internal conformity assessments.
- Compliance engineers and regulatory teams - to structure supplier data collection, evaluate exemptions and prepare declarations of conformity.
- Supply chain managers and procurement - to specify required supplier documentation (material declarations, test reports) and traceability requirements.
- Testing laboratories and conformity assessors - to understand the expected documentation context and how test reports feed into the technical file. Practical uses include preparing documentation for market surveillance, answering enforcement queries, supporting product design decisions to avoid restricted hazardous substances, and streamlining supplier communication for material declarations.
Related Standards
- EN 50581:2012 (predecessor; EN IEC 63000 was developed based on this)
- IEC 62321 series - methods for determination of certain substances in electrotechnical products
- IEC 62474:2012 - material declaration for the electrotechnical industry
- Reference to RoHS Directive 2011/65/EU (relationship and presumption of conformity when cited in the Official Journal)
Keywords: EN IEC 63000:2018, IEC 63000, technical documentation, RoHS compliance, restricted hazardous substances, material declaration, supplier declaration, IEC 62321, IEC 62474.
Frequently Asked Questions
SIST EN IEC 63000:2019 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances". This standard covers: IEC 63000:2016 specifies the technical documentation that the manufacturer compiles in order to declare compliance with the applicable substance restrictions
IEC 63000:2016 specifies the technical documentation that the manufacturer compiles in order to declare compliance with the applicable substance restrictions
SIST EN IEC 63000:2019 is classified under the following ICS (International Classification for Standards) categories: 01.110 - Technical product documentation; 29.020 - Electrical engineering in general; 31.020 - Electronic components in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN IEC 63000:2019 has the following relationships with other standards: It is inter standard links to SIST EN 50581:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN IEC 63000:2019 is associated with the following European legislation: EU Directives/Regulations: 2011/65/EU; Standardization Mandates: M/499. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN IEC 63000:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2019
Nadomešča:
SIST EN 50581:2012
Tehnična dokumentacija za presojo električnih in elektronskih naprav v zvezi z
omejitvami pri nevarnih snoveh
Technical documentation for the assessment of electrical and electronic products with
respect to the restriction of hazardous substances
Documentation technique pour l'évaluation des produits électriques et électroniques par
rapport à la restriction des substances dangereuses
Ta slovenski standard je istoveten z: EN IEC 63000:2018
ICS:
01.110 Tehnična dokumentacija za Technical product
izdelke documentation
29.020 Elektrotehnika na splošno Electrical engineering in
general
31.020 Elektronske komponente na Electronic components in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 63000
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2018
ICS 01.040.01; 13.030.10; 31.120 Supersedes EN 50581:2012
English Version
Technical documentation for the assessment of electrical and
electronic products with respect to the restriction of hazardous
substances
(IEC 63000:2016)
Documentation technique pour l'évaluation des produits Technische Dokumentation zur Beurteilung von Elektro-
électriques et électroniques par rapport à la restriction des und Elektronikgeräten hinsichtlich der Beschränkung
substances dangereuses gefärlicher Stöffe
(IEC 63000:2016) (IEC 63000:2016)
This European Standard was approved by CENELEC on 2017-08-31. CENELEC 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.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63000:2018 E
European foreword
The text of document 111/413/CDV, future edition 1 of IEC 63000, prepared by
IEC/TC 111 "Environmental standardization for electrical and electronic products and systems" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 63000:2018.
The following dates are fixed:
• latest date by which the document has to be (dop) 2019-06-07
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2023-12-07
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 50581:2012. IEC 63000 is based on EN 50581:2012. Given the
widespread acceptance of EN 50581:2012, it was decided to keep the text as close as possible to the
original document, and to limit the changes to the minimum necessary to reflect the latest status of
international standardization in this area.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive
2011/65/EU.
For the relationship with the EU Directive, see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 63000:2016 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 62430:2009 NOTE Harmonized as EN 62430:2009.
IEC 62542:2013 NOTE Harmonized as EN 62542:2013.
ISO 9001 NOTE Harmonized as EN ISO 9001.
ISO 14001 NOTE Harmonized as EN ISO 14001.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 62321 series Determination of certain substances in EN 62321 series
electrotechnical products
IEC 62474 2012 Material declaration for products of and for EN 62474 2012
the electrotechnical industry
Annex ZZ
(informative)
Relationship between this European standard and the requirements of
Directive 2011/65/EU aimed to be covered
This European Standard has been prepared under a Commission’s standardization request “M/499” /
”Ares(2011)1152542” to provide one voluntary means of conforming to the requirements of Directive
2011/65/EU of 8 June 2011 (OJEU of 1 July 2011) on the Restriction of the Use of Certain Hazardous
Substances in Electrical and Electronic Equipment (RoHS recast Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZZ.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding requirements of that
Directive and associated EFTA regulations.
Table ZZ.1 – Correspondence between this European standard and the requirements of
Directive 2011/65/EU of 8 June 2011 (OJEU of 1 July 2011)
Clause(s) / sub-clause(s)
Requirements of Directive
Remarks / Notes
2011/65/EU
of this EN
Article 7 (b) and (e) Clause 4 Compliance with clause 4 of this
Harmonised Standard ensures
that the technical documentation
is drawn up in accordance with
the requirements of the
Directive
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
IEC 63000 ®
Edition 1.0 2016-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Technical documentation for the assessment of electrical and electronic
products with respect to the restriction of hazardous substances
Documentation technique pour l'évaluation des produits électriques et
électroniques par rapport à la restriction des substances dangereuses
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 01.040.01; 13.030.10; 31.020 ISBN 978-2-8322-3649-9
– 2 – IEC 63000:2016 © IEC 2016
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references. 6
3 Terms and definitions . 6
4 Technical documentation . 6
4.1 Overview. 6
4.2 Content of the technical documentation . 7
4.3 Information on materials, parts, and/or sub-assemblies . 7
4.3.1 Tasks to be undertaken by the manufacturer . 7
4.3.2 Determine the information needed . 8
4.3.3 Collecting information . 8
4.3.4 Evaluation of information . 9
4.3.5 Review of the technical documentation . 9
Bibliography . 10
Figure 1 – Schematic representation of process to create the technical documentation . 7
IEC 63000:2016 © IEC 2016 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
TECHNICAL DOCUMENTATION FOR THE ASSESSMENT
OF ELECTRICAL AND ELECTRONIC PRODUCTS WITH RESPECT
TO THE RESTRICTION OF HAZARDOUS SUBSTANCES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC 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) 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 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 nearly 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 that 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 Committees undertake to apply IEC Publications
transparently to the maximum extent possible in th
...
Die SIST EN IEC 63000:2019 bietet eine umfassende Grundlage für die technische Dokumentation zur Bewertung elektrischer und elektronischer Produkte in Bezug auf die Einschränkung gefährlicher Substanzen. Der Umfang dieser Norm ist darauf ausgelegt, Herstellern zu helfen, die erforderliche Dokumentation zu erstellen, um die Einhaltung der geltenden Stoffbeschränkungen zu deklarieren. Dies ist besonders relevant im Kontext der globalen Bemühungen, umweltfreundliche Produkte zu fördern und die Sicherheit der Verbraucher zu gewährleisten. Zu den Stärken der SIST EN IEC 63000:2019 gehört die klare Struktur, die es Herstellern ermöglicht, die notwendigen Informationen systematisch zusammenzustellen. Die Norm fördert die Transparenz bei der Verwendung von Materialien und Substanzen, was nicht nur den gesetzlichen Anforderungen entspricht, sondern auch das Vertrauen der Verbraucher in die Produkte erhöht. Der Fokus auf die Dokumentation unterstützt eine effektive Nachverfolgbarkeit und Verantwortlichkeit in der Lieferkette. Darüber hinaus schafft die Norm eine harmonisierte Grundlage für die Bewertung von Produkten auf internationaler Ebene. Dies erleichtert den Herstellern den Zugang zu globalen Märkten, da die Einhaltung der Normen dazu beiträgt, regulatorische Hürden zu überwinden und Wettbewerbsfähigkeit zu sichern. Die Relevanz der SIST EN IEC 63000:2019 wird durch die fortwährenden Entwicklungen in der Gesetzgebung zu gefährlichen Stoffen unterstrichen, die Unternehmen dazu zwingt, sich kontinuierlich an die Richtlinien anzupassen. Insgesamt liefert die SIST EN IEC 63000:2019 eine entscheidende Hilfestellung für die Industrie, um die Herausforderungen rund um die Beschränkung gefährlicher Substanzen zu bewältigen und gleichzeitig Umwelt- und Sicherheitsstandards zu erfüllen.
La norme SIST EN IEC 63000:2019 se distingue par son approche complète en matière de documentation technique relative à l'évaluation des produits électriques et électroniques concernant les restrictions sur les substances dangereuses. Cette standardisation vise à fournir un cadre clair pour la rédaction et la compilation des documents nécessaires à la déclaration de conformité, garantissant ainsi que les fabricants respectent les exigences légales en vigueur. L'un des points forts de cette norme réside dans sa précision quant aux exigences et aux meilleures pratiques pour les fabricants. En spécifiant les éléments techniques à inclure dans la documentation, la norme facilite non seulement le respect des restrictions sur les substances dangereuses, mais renforce également la transparence et la traçabilité des produits sur le marché. Cette clarté permet aux entreprises de mieux gérer leurs risques liés à la non-conformité avec les réglementations. De plus, la pertinence de la norme SIST EN IEC 63000:2019 est accentuée par l'importance croissante accordée à la durabilité et à la sécurité des produits électriques et électroniques. Alors que les consommateurs deviennent de plus en plus conscients des impacts environnementaux des produits qu'ils achètent, cette norme joue un rôle crucial en aidant les fabricants à démontrer leur engagement envers des pratiques responsables et respectueuses de l'environnement. En résumé, la norme SIST EN IEC 63000:2019 est un outil essentiel pour les fabricants d'équipements électriques et électroniques, les guidant dans la collecte et l'organisation de la documentation technique nécessaire à la conformité avec les restrictions sur les substances dangereuses. Elle assure ainsi un niveau élevé de sécurité et de durabilité pour les produits mis sur le marché.
SIST EN IEC 63000:2019は、電気および電子製品に関する有害物質の制限に対する評価のための技術文書に関する標準であり、製造者が適用される物質制限に準拠していることを宣言するために必要な技術文書を明確に規定しています。この標準は、環境保護や人の健康に配慮した製品設計を促進する重要な枠組みを提供します。 このSIST EN IEC 63000:2019の強みは、製造者が遵守すべき明確なプロセスを示している点にあります。具体的には、製品の材料、部品、最終製品に対する含有物質の評価方法が詳細に説明されており、製品のライフサイクル全般を通じたコンプライアンスの確保が可能です。また、異なる市場や地域における規制基準に対応できる柔軟性を持っており、国際的なビジネス環境において特に重要です。 さらに、この標準は有害物質の制限に関する最新の技術や研究成果を反映しており、業界のニーズに適応しています。そのため、製造者は法令遵守を的確に行うだけでなく、消費者や環境に対する責任を果たすことができます。この点が、SIST EN IEC 63000:2019の関連性を高めており、業界全体における持続可能な成長を支える役割を果たしています。
SIST EN IEC 63000:2019는 위험 물질 제한에 관한 전기 및 전자 제품의 평가를 위한 기술 문서를 규정하는 중요한 표준입니다. 이 표준은 IEC 63000:2016의 내용을 바탕으로 하여 제조업체가 적용 가능한 물질 제한에 대한 준수를 선언하기 위해 작성해야 하는 기술 문서를 상세히 설명합니다. 이 표준의 범위는 전기 및 전자 제품의 설계, 제조 및 유통 과정에서 발생할 수 있는 위험 물질을 효과적으로 관리하고 규제하기 위한 기초를 마련해줍니다. 특히, 환경 보호 및 인간 건강을 고려하여 유해 물질 사용에 대한 엄격한 가이드라인을 제공합니다. 이러한 접근은 기업들이 법적 요구 사항을 준수하고, 안전한 제품 생산을 도모하는 데 필수적입니다. SIST EN IEC 63000:2019의 강점은 그 명확성과 체계성에 있습니다. 표준은 제품의 기술 문서화를 위한 구체적인 요구 사항을 상세히 명시하고 있어, 제조업체들이 준수해야 할 기준을 쉽게 이해하고 적용할 수 있도록 돕습니다. 또한, 이 표준은 다양한 산업에서의 통일성을 촉진하여 국제적인 시장에서도 신뢰받는 규정을 제공합니다. 이 표준의 적 relevance은 전 세계적으로 증가하는 환경 규제와 함께 더욱 더 주목받고 있습니다. 소비자와 규제 기관들이 안전하고 환경 친화적인 제품을 요구함에 따라, SIST EN IEC 63000:2019는 기업들이 시장에서 경쟁력을 유지하고 사회적 책임을 다하는 데 필수적인 도구가 되고 있습니다. 전반적으로, 이 표준은 전기 및 전자 제품의 안전성과 환경적 지속 가능성을 보장하는 데 매우 유용한 지침을 제공합니다.
The SIST EN IEC 63000:2019 standard is a crucial document that establishes a comprehensive framework for the technical documentation required for assessing electrical and electronic products concerning the restriction of hazardous substances. This standard delineates the specific information manufacturers must compile to ensure compliance with substance restrictions, thereby enhancing product safety and environmental protection. One of the principal strengths of SIST EN IEC 63000:2019 is its detailed guidance on the kind of documentation necessary for demonstrating adherence to regulatory requirements. This clarity helps manufacturers understand their obligations and facilitates a smoother compliance process, which is essential in today's highly regulated marketplace. The standard underscores the importance of transparency and traceability in the supply chain, thereby promoting responsible manufacturing practices. Additionally, the relevance of this standard cannot be overstated, especially as global awareness of hazardous substances continues to grow. As environmental regulations become more stringent, adherence to SIST EN IEC 63000:2019 will be vital for manufacturers aiming to market their electrical and electronic products internationally. The emphasis on rigorous documentation not only ensures compliance but also fosters trust among consumers and stakeholders, reinforcing the industry's commitment to sustainability. In summary, the SIST EN IEC 63000:2019 standard effectively addresses the increasing demand for detailed technical documentation in the assessment of electrical and electronic products. Its strengths in clarity, compliance facilitation, and relevance to environmental standards make it an indispensable tool for manufacturers navigating the complexities of hazardous substance restrictions.
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