--- title: "EN IEC 63000 RoHS Technical Documentation" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/en-iec-63000-technical-documentation" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/en-iec-63000-technical-documentation" author: "Sorena AI" description: "source-linked guide to EN IEC 63000:2018 technical documentation for EU RoHS, including manufacturer duties, evidence records, harmonised-standard status, and file maintenance." published_at: "2026-05-09" updated_at: "2026-05-27" keywords: - "EN IEC 63000" - "IEC 63000" - "RoHS technical documentation" - "EU RoHS evidence" - "Directive 2011/65/EU" - "RoHS harmonised standard" - "EU RoHS Directive" - "RoHS compliance evidence" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # EN IEC 63000 RoHS Technical Documentation source-linked guide to EN IEC 63000:2018 technical documentation for EU RoHS, including manufacturer duties, evidence records, harmonised-standard status, and file maintenance. *Artifact Guide* *EU* ## EU RoHS Directive EN IEC 63000 technical documentation EN IEC 63000:2018 is the harmonised RoHS technical-documentation standard cited in Commission Implementing Decision (EU) 2020/659 for assessing materials, components, and electrical and electronic equipment against restricted-substance requirements. Use this guide to structure a RoHS technical file around product identity, restricted-substance evidence, supplier inputs, test decisions, exemptions, declarations, and update triggers. EN IEC 63000 is useful because it gives teams a standardised way to compile the technical documentation behind a RoHS Declaration of Conformity. Directive 2011/65/EU still supplies the legal duties: manufacturers must draw up technical documentation, use the internal production control procedure, issue the EU Declaration of Conformity when compliance is demonstrated, affix CE marking, and keep the technical documentation and declaration for 10 years after the EEE is placed on the market. ## What EN IEC 63000 does for a RoHS file Commission Implementing Decision (EU) 2020/659 published EN IEC 63000:2018 in the Official Journal as the harmonised standard for technical documentation required to assess materials, components, and EEE in support of Directive 2011/65/EU. The same decision says the standard sets out specifications for documentation used to assess conformity with RoHS hazardous-substance restrictions. That makes the standard a documentation method, not a substitute for the RoHS substance restrictions themselves. The technical file still has to connect the finished EEE and its materials or components to Article 4 restrictions, Annex II maximum concentration values, any exemption relied on, and the evidence used to support the declaration. - Use EN IEC 63000:2018 as the cited technical-documentation framework when building the RoHS evidence file. - Keep the RoHS legal basis visible beside the standard reference: Article 7 manufacturer duties, Article 16 presumption of conformity, Annex II concentration values, and applicable exemptions. - Do not treat a supplier's generic RoHS statement as the whole file; connect supplier information, material declarations, and any test evidence to the exact product or component being assessed. Sources for this answer: - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source publishing EN IEC 63000:2018 as the RoHS harmonised standard for technical documentation. - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding consolidated RoHS source for manufacturer duties, substance restrictions, concentration values, exemptions, CE marking, and retention. ## Evidence to compile before signing the RoHS declaration The starting point is a stable product identity: model, type, batch, serial number, or another identifier that matches the finished EEE named in the Declaration of Conformity. From there, the technical file should show how the materials and components were assessed against the restricted substances and maximum concentration values by weight in homogeneous materials. The IEC publisher page describes IEC 63000:2016 as specifying the technical documentation the manufacturer compiles to declare compliance with applicable substance restrictions. It also lists IEC 62321 parts and IEC 62474 material declaration as normative references or related standards, which is why many RoHS files combine supplier declarations, material declarations, and targeted test evidence rather than relying on one evidence type. - Map the bill of materials and material declarations to RoHS Annex II substances: lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. - Record which supplier declarations, material declarations, risk assessments, and test reports were used, and where evidence was unavailable or not needed. - Keep exemption reasoning separate from substance evidence so each exemption can be reviewed against its exact Annex III or Annex IV entry and expiry position. Sources for this answer: - [IEC 63000:2016 product page](https://webstore.iec.ch/en/publication/25985?ref=sorena.io) - IEC publisher page for IEC 63000:2016, including scope, publication details, and related IEC 62321 and IEC 62474 references. - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for Annex II restricted substances and maximum concentration values in homogeneous materials. *Recommended next step* *Placement: after implementation section* ## Review your EN IEC 63000 evidence file Use this guide to check whether your RoHS technical documentation ties EN IEC 63000 to product identity, Annex II substance evidence, supplier inputs, exemption reasoning, test decisions, DoC ownership, and 10-year retention controls. - [Open Research Copilot](/solutions/research-copilot.md): Answer RoHS technical-documentation, standard, and evidence questions with cited outputs. - [Talk through implementation](/contact.md): Review your technical file, supplier evidence, exemption reasoning, and release controls. ## Harmonised-standard status and version control The EU harmonised-standard citation matters because Directive 2011/65/EU provides a presumption-of-conformity route for materials, components, and EEE assessed in accordance with harmonised standards whose references have been published in the Official Journal. The Commission's RoHS harmonised-standards page points readers to Commission Implementing Decision (EU) 2020/659 for the current Official Journal publication context. Decision (EU) 2020/659 says EN IEC 63000:2018 replaced EN 50581:2012 and withdrew the EN 50581:2012 reference from the Official Journal from 18 November 2021. The IEC product page also shows IEC 63000:2016 as a 2016-10-04 international standard, with an amendment and consolidated version published on 2022-01-14. - Cite EN IEC 63000:2018 for EU RoHS harmonised-standard purposes, not only the base IEC 63000:2016 publisher page. - Keep a controlled record of the standard version, declaration date, evidence date range, and any later supplier or product changes. - Reopen the file when the product design, material composition, supplier source, exemption reliance, harmonised standard, or technical specification used for the declaration changes. Sources for this answer: - [European Commission - harmonised standards for RoHS](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en?ref=sorena.io) - Commission page for RoHS harmonised-standard references and Official Journal publication context. - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source for EN IEC 63000:2018 publication, EN 50581:2012 replacement, and the 18 November 2021 withdrawal date. - [IEC 63000:2016 product page](https://webstore.iec.ch/en/publication/25985?ref=sorena.io) - IEC publisher page showing publication date, amendment, consolidated version, and validity details for IEC 63000. ## Controls that keep the technical documentation usable RoHS technical documentation is a release-control artifact. Article 7 requires manufacturers to keep the technical documentation and EU Declaration of Conformity for 10 years after the EEE has been placed on the market, and to ensure procedures are in place so series production remains in conformity. A useful EN IEC 63000 file therefore needs update triggers, not only a static launch checklist. The file should say who owns supplier evidence review, who approves test decisions, who monitors exemption and standard changes, and how the company responds if a market surveillance authority asks for the documentation. - Store the signed DoC, technical documentation index, BOM evidence, supplier declarations, material declarations, exemption analysis, test reports where used, and change-control decisions together. - Define review triggers for component substitutions, supplier changes, material changes, exemption expiry changes, restricted-substance updates, and harmonised-standard changes. - Keep importer and distributor access expectations clear when they need enough documentation assurance to verify CE marking, required documents, and product identity before making EEE available on the EU market. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for technical documentation retention, series-production controls, importer and distributor checks, and authority-response duties. - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - General EU product-law guidance for economic operator roles, technical documentation, declarations, and market surveillance expectations. ## Primary sources - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding consolidated RoHS source for manufacturer duties, technical documentation, EU Declaration of Conformity, CE marking, retention, restricted substances, concentration values, exemptions, and economic-operator checks. - Quote: "manufacturers draw up the required technical documentation" - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source identifying EN IEC 63000:2018 as the harmonised standard for RoHS technical documentation and withdrawing EN 50581:2012 from 18 November 2021. - Quote: "Technical documentation for the assessment of electrical and electronic products" - [European Commission - harmonised standards for RoHS](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en?ref=sorena.io) - Commission page for RoHS harmonised-standard references and Official Journal publication and withdrawal context. - Quote: "references of harmonised standards are published" - [IEC 63000:2016 product page](https://webstore.iec.ch/en/publication/25985?ref=sorena.io) - IEC publisher page for IEC 63000:2016, including scope, publication details, amendment, consolidated version, and related references. - Quote: "specifies the technical documentation" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - General EU product-law guidance for conformity assessment, declarations, technical documentation, economic operators, and market surveillance. - Quote: "The manufacturer is responsible for the conformity assessment" ## Related Topic Guides - [Are cables in scope of EU RoHS? Cable evidence, CE marking, and DoC FAQ](/artifacts/eu/rohs-directive/faq/cables.md): EU RoHS cable FAQ covering when cables are EEE, how internal and external cables are treated, when separate CE marking and a DoC are needed, and what evidence to keep. - [Do Components Need EU RoHS Compliance? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/components.md): RoHS FAQ for components in electrical and electronic equipment: substance restrictions, homogeneous materials, CE marking, technical files, exemptions, and supplier evidence. - [EU RoHS Annex III and IV exemptions guide](/artifacts/eu/rohs-directive/annex-iii-and-iv-exemptions.md): How to use, renew, or challenge EU RoHS Annex III and Annex IV exemptions, with Article 5 criteria, timing rules, and evidence requirements. - [EU RoHS Applicability Test for EEE Scope](/artifacts/eu/rohs-directive/applicability-test.md): Decide whether EU RoHS applies to electrical and electronic equipment, cables, spare parts, exclusions, exemptions, CE marking, and evidence records. - [EU RoHS CE Marking and Declaration of Conformity](/artifacts/eu/rohs-directive/ce-and-doc.md): source-linked guide to RoHS CE marking, EU Declaration of Conformity, technical documentation, EN IEC 63000, and importer or distributor checks. - [EU RoHS compliance checklist for EEE](/artifacts/eu/rohs-directive/checklist.md): Checklist for EU RoHS scope, restricted substances, homogeneous materials, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Compliance Guide for EEE](/artifacts/eu/rohs-directive/compliance.md): Practical EU RoHS compliance guide for electrical and electronic equipment: scope, restricted substances, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Deadlines and Compliance Calendar](/artifacts/eu/rohs-directive/deadlines-and-compliance-calendar.md): source-linked RoHS calendar for scope phase-ins, phthalate dates, exemption renewals, spare-parts cutoffs, EN IEC 63000, CE files, and review triggers. - [EU RoHS Declarations vs Lab Tests FAQ](/artifacts/eu/rohs-directive/faq/declarations-vs-lab-tests.md): When supplier declarations can support EU RoHS technical documentation, when IEC 62321 lab testing is stronger evidence, and how to document the decision. - [EU RoHS Directive FAQ: scope, substances, CE marking](/artifacts/eu/rohs-directive/faq.md): Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions. - [EU RoHS EEE Categories and Open Scope](/artifacts/eu/rohs-directive/eee-categories-and-open-scope.md): Map products to EU RoHS EEE categories, category 11 open scope, Article 2 exclusions, cables, spare parts, and evidence needed for RoHS scope decisions. - [EU RoHS for medical devices and monitoring equipment](/artifacts/eu/rohs-directive/medical-devices-and-monitoring-equipment.md): RoHS category 8 and 9 guide covering application dates, Annex IV exemptions, phthalates, spare parts, CE marking, declarations, and technical documentation. - [EU RoHS penalties and fines: Member State sanctions](/artifacts/eu/rohs-directive/penalties-and-fines.md): source-linked guide to EU RoHS penalty exposure: national sanctions, no EU-wide fine table, CE marking misuse, corrective actions, recalls, and evidence records. - [EU RoHS Phthalates: DEHP, BBP, DBP, DIBP](/artifacts/eu/rohs-directive/phthalates.md): source-linked RoHS guide to DEHP, BBP, DBP, and DIBP: 0.1% homogeneous-material limits, 2019 and 2021 application dates, exemptions, evidence, and testing standards. - [EU RoHS requirements for EEE, substances, and CE evidence](/artifacts/eu/rohs-directive/requirements.md): Practical EU RoHS requirements guide covering EEE scope, Annex II substance limits, exemptions, technical documentation, EU declaration of conformity, CE marking, and operator evidence. - [EU RoHS Restricted Substances and Thresholds | Annex II Limits](/artifacts/eu/rohs-directive/restricted-substances-and-thresholds.md): EU RoHS Annex II restricted substances and maximum concentration values by weight in homogeneous materials, including cadmium's 0.01% limit and the 0.1% limits for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. - [EU RoHS Spare Parts: Repair and Reuse](/artifacts/eu/rohs-directive/spare-parts.md): source-linked RoHS spare-parts guide covering Article 4 repair parts, reused recovered parts, closed-loop conditions, phthalate carve-outs, CE evidence, and cutoff dates. - [EU RoHS test plan selection workflow](/artifacts/eu/rohs-directive/test-plan-selection-workflow.md): Choose RoHS supplier evidence, EN IEC 63000 technical documentation, and IEC 62321 testing without over-testing or under-documenting restricted substances. - [How should RoHS lead, mercury, and cadmium exemptions be documented? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/lead-mercury-and-cadmium-exemptions.md): RoHS FAQ on documenting lead, mercury, and cadmium exemptions with Annex III or IV entries, material-level limits, expiry status, supplier evidence, and technical documentation. - [RoHS BOM evidence intake workflow](/artifacts/eu/rohs-directive/bom-evidence-intake-workflow.md): Build a RoHS BOM evidence intake process for EEE: map parts to homogeneous materials, collect supplier declarations, handle exemptions, and feed EN IEC 63000 technical documentation. - [RoHS exemption register workflow: expiry, renewal, evidence](/artifacts/eu/rohs-directive/exemption-register-workflow.md): Build a RoHS exemption register that tracks Annex III and IV entries, product scope, expiry dates, renewal status, evidence owners, and Commission source links. - [RoHS exemptions tracker guide: fields, evidence, gates](/artifacts/eu/rohs-directive/rohs-exemptions-tracker-guide.md): Build a RoHS exemptions tracker for Annex III and IV claims, renewal timing, supplier evidence, EN IEC 63000 documentation, and release decisions. - [RoHS Exemptions Tracking Register](/artifacts/eu/rohs-directive/exemptions-tracking.md): Track EU RoHS Annex III and IV exemptions by material, component, category, expiry date, renewal status, Article 5 rationale, and evidence record. - [RoHS Homogeneous Material Definition and Limits](/artifacts/eu/rohs-directive/faq/homogeneous-material.md): Plain-English EU RoHS FAQ on homogeneous materials, Annex II thresholds, coatings, cables, assemblies, and evidence needed for material-level RoHS decisions. - [RoHS Homogeneous Material Thresholds](/artifacts/eu/rohs-directive/homogeneous-material-thresholds.md): EU RoHS guide to homogeneous material thresholds: 0.1% limits, the 0.01% cadmium limit, material splitting, coatings, samples, exemptions, and technical evidence. - [RoHS importer checks for imported EEE before EU market placement](/artifacts/eu/rohs-directive/faq/imported-eee.md): Importer-focused RoHS FAQ covering CE marking, EU declaration of conformity, technical documentation availability, importer identity, nonconformity handling, and 10-year DoC retention. - [RoHS Risk-Based Testing Guide](/artifacts/eu/rohs-directive/risk-based-testing.md): source-linked EU RoHS guide to risk-based testing, EN IEC 63000 documentation, IEC 62321 methods, supplier evidence, and technical-file decisions. - [RoHS Supplier Change Control Workflow](/artifacts/eu/rohs-directive/supplier-change-control-workflow.md): source-linked EU RoHS supplier change control workflow for part substitutions, material changes, supplier declarations, testing decisions, and technical-file updates. - [RoHS Supplier Declaration Template](/artifacts/eu/rohs-directive/rohs-supplier-declaration-template.md): source-linked EU RoHS supplier declaration template guidance for collecting material evidence, exemption claims, test records, and EN IEC 63000 technical-file inputs. - [RoHS Supplier Declarations and Verification Guide](/artifacts/eu/rohs-directive/supplier-declarations-and-verification.md): Build a RoHS supplier evidence file without confusing supplier declarations with manufacturer EU DoC, CE marking, technical documentation, or importer checks. - [RoHS Supplier Declarations Guide](/artifacts/eu/rohs-directive/supplier-declarations.md): Use RoHS supplier declarations as supporting evidence for BOM, material, exemption, and technical-file reviews without replacing manufacturer EU DoC or CE duties. - [RoHS technical documentation, EU DoC and CE marking](/artifacts/eu/rohs-directive/technical-documentation-and-ce.md): source-linked guide to RoHS technical documentation, EN IEC 63000 evidence, EU declarations of conformity, CE marking, and manufacturer, importer and distributor duties. - [RoHS Timeline: practical guide](/artifacts/eu/rohs-directive/timeline.md): EU RoHS Directive guide to Timeline with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps. - [RoHS vs Batteries Regulation scope comparison](/artifacts/eu/rohs-directive/rohs-vs-batteries-regulation.md): RoHS-focused comparison explaining when RoHS applies to EEE, why batteries sit outside RoHS, and what evidence should not be reused without separate battery-law support. - [RoHS vs LVD/EMC CE evidence: what belongs in the RoHS file](/artifacts/eu/rohs-directive/rohs-vs-lvd-emc-ce-evidence.md): Compare RoHS substance evidence with separate LVD and EMC CE evidence streams, using RoHS-grounded scope, technical file, DoC, CE marking, exemption, and supplier records. - [RoHS vs POPs for EEE substance compliance](/artifacts/eu/rohs-directive/rohs-vs-pops.md): Compare EU RoHS and POPs obligations for electrical and electronic equipment: scope, substances, evidence, CE files, exemptions, waste overlap, and source-linked decision rules. - [RoHS vs REACH for electronics: scope, evidence, overlap](/artifacts/eu/rohs-directive/rohs-vs-reach.md): Compare EU RoHS and REACH for electrical and electronic equipment: scope, restricted substances, evidence, CE marking, exemptions, and overlap decisions. - [RoHS vs WEEE: EU electronics compliance comparison](/artifacts/eu/rohs-directive/rohs-vs-weee.md): Compare EU RoHS restricted-substance duties with WEEE end-of-life recycling obligations, with RoHS scope, evidence, CE marking, exemptions, and source-linked decision points. - [RoHS, REACH, POPs, and batteries overlap](/artifacts/eu/rohs-directive/reach-pop-and-batteries-overlap.md): source-linked RoHS comparison guide for separating EEE hazardous-substance restrictions from REACH, POPs, battery, waste, and technical-file workstreams. - [What do the 0.1% and 0.01% substance limits mean under EU RoHS? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/0-1-and-0-01-limits.md): RoHS FAQ explaining why most Annex II substances use a 0.1% homogeneous-material limit while cadmium uses 0.01%. - [What should teams do before a RoHS exemption expires? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/exemption-expiry.md): How to handle EU RoHS exemption expiry: confirm the Annex entry, renewal deadline, pending-decision status, fallback plan, and technical-file evidence. - [When can RoHS spare parts use transition rules? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/spare-parts.md): EU RoHS FAQ on spare parts, repair parts, reused parts, closed-loop B2B reuse, legacy EEE cutoffs, Annex III and IV exemptions, and evidence to keep. - [Which EEE is in scope under EU RoHS? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/eee-scope.md): EU RoHS scope FAQ explaining when a product is electrical and electronic equipment, which Article 2 exclusions to check, and what evidence to keep. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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