REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance)
機械に関する2023年6月14日付欧州議会および理事会規則 (EU) 2023/1230
欧州議会および理事会指令 2006/42/EC および理事会指令 73/361/EEC を廃止する (EEA関連文書)
[2] Clause (15) 第(15)章
In order to ensure that the scope of this Regulation is sufficiently clear, a distinction should be made between machinery, related products and partly completed machinery.
Moreover, related products should be understood as comprising interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices, which are all products within the scope of this Regulation.
The evolution of the machinery sector has resulted in the growing use of digital means and software plays a more and more important role in machinery design.
Consequently, the definition of machinery should be adapted.
In this respect, machinery missing only the upload of software intended for the specific application foreseen by the manufacturer, and which is the subject of the conformity assessment procedure of the machinery, should fall under the definition of machinery and not under the definitions of related products or partly completed machinery. Furthermore,
the definition of safety components should cover not only physical devices but also digital devices. In order to take into account the increasing use of software as a safety component, software that performs a safety function and which is placed independently on the market should be considered a safety component.
Considering their critical protective function, certain components included in the indicative list of safety components in Annex II should also be subject to specific conformity assessment procedures and included in Annex I.
機械規則では、安全コンポーネントは、安全機能を果たすように設計、又は意図したもので独立して市場に投入されるもとの定義している。
通常、安全規格における重要部品は、CDF（Construction Data Form）と言われ、テストレポート(Safety Test Report)に重要部品表としてレポートに添付される。
【参考】 機械規則（REGULATION (EU) 2023/1230
Article 3 第3条
Definitions 定義
(3) Safety component’ means a physical or digital component, including software, of a product within the scope of this Regulation, which is designed or intended to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endanger the safety of persons, but which is not necessary in order for that product to function or for which normal components may be substituted in order for that product to function;
[2] 製品安全設計における重要部品とは？
基本は、安全に関係する部品(Parts)・部組品(Sub-assembly)が対象となるが、対象製品によってその違いがあることやまた、何が重要となるかについては、設計段階における規格要求、及び設計者の部品選定の考え方に依存する。
例えば、安全規格 IEC 61010-1(検査･計測機器)の場合、電気関係を中心にした規格要求に従った重要部品のリストアップの要求が有り、CDF(Construction Data Form)の作成が要求されている。
TABLE: List of components and circuits relied on for safety (IEC 61010-1)
Unique component reference or location (including drawing reference if required) 部品、及び回路上の位置
Application/Function
適用、及び機能
Manufacturer (NOTE 1)
製造メーカー
Part number
部品の型名(タイプ)
RATING (NOTE 2)
部品定格 (仕様)
Evidence of acceptance (NOTE 3)
適用規格 (認定No.)
NOTE 1 - List all manufacturers concerned.
NOTE 2 - Electrical, mechanical, flammability, etc.
NOTE 3 - Licence number, file number or other documentary evidence of acceptance
■NFPA 79:2021 (National Fire Protection Association)
Electrical Standard for Industrial Machinery 産業機械の電気規格 https://www.nfpa.org/
産業機械･機器の感電や火災の防止が目的で、1000V以下の公称電圧の機械の電気・電子装置に適用する。
（産業機械の電気 / 電子機器 / 部品、装置、又はシステムなど、電力供給の接続点から機械の電気機器）
例）工作機械、射出成型機、木工機械、組立機械、材料管理用設備機械、検査及び試験用、ドラッグチェーン
●NFPA79:2021年版の主なポイント
NFPA79 [第1章 管理]
前提としてNFPA79 に記載のない項目に関しては、NFPA70 / NECを参照する必要がある。
※NFPA70 / NEC (The National Electrical Code)：米国電気工事規程
機械・装置、電気設備など、工場建屋、機械工場などの特定のエリアに設置する際の工事規定であり、検査･計測機器などの電源設備の保護のある環境に設置する装置は、NFPA70の対象外と解釈
1. 5 Specific Provisions Not Made in Relation to NFPA 70.
On any point for which specific provisions are not made in this standard the provisions of NFPA 70 shall be observed.
4.4.2.8 Circuits Supplied From Power Conversion Equipment.
Electrical conductors and equipment supplied by power conversion equipment as part of adjustable speed drive systems and servo drive systems shall be listed flexible motor supply cablemarked type RHH, RHW, RHW-2, XHH, XHHW, or XHHW-2 or selected based on the equipment manufacturer’s instructions.
※参照: NFPA79 [第12章 導体、ケーブル、フレキシブルコード]
【絶縁体の定義（NFPA79 12.3）】
ULでは絶縁体の種類を定義していて、NFPA79 4.4.2.8でいう絶縁体は、NFPA79 12.3で説明
（絶縁体: 電気、又は熱を通しにくい性質がある物質）
機器内配線用電線(AWM)は、メーカー指示に従いULリステッド認証のある機器・装置内で使用できる。
*AMW: Appliance Wiring Material
12. 9 Special Cables and Conductors
12.9.1 Other listed cables and conductors shall be permitted where identified as suitable for the intended use.
12.9.2 appliance wiring material (AWM) shall be permitted under any of the following conditions
(1) Where part of an assembly that has been identified for the intended use.
(2) Where7 the AWM has been identified for use with approved equipment and is used in accordance with the equipment manufacturer’s instructions.
(2) 米国(NFPA79)のケーブル選定と配線
北米向けの機械・電気装置のケーブル選定は特に重要で、産業機械や機器の設置や据付工事の監査において、規制当局のAHJ（Authority Having Jurisdiction）の検査で不適合と判断される場合がある。
結果、現地での改造や安全性試験機関による個別の対応が必要となって、費用、工期の延長の原因となる。
NFPA 79：2018 *Electrical Standard for Industrial Machinery（産業機械用電気安全規格）
Section 7.8.1：“Surge Protective Devices（SPDs）.
SPDs shall be provided for industrial machinery with safety interlock circuits to protect against the effects of overvoltages due to lightning or switching surges.”
*IEC 60825-1(Safety of laser products –Part 1: Equipment classification and requirements)
EN/IEC 62368-1:2020
10.3 Safeguards against laser radiation
Equipment containing one or more lasers (including laser diodes) shall comply with IEC 60825-1, IEC 60825-2 or IEC 60825-12 as applicable.
Unless RS2 is required to be accessible for the function of the equipment, laser radiation that exits the equipment shall not exceed RS1 under normal operating conditions, abnormal operating conditions, and single fault conditions.
If RS2 is required to be accessible for the function of the equipment, the equipment shall be provided with an instructional safeguard in accordance with IEC 60825-1.
Unless the equipment complies with IEC 60825-2, where an RS3 laser is present, a tool shall be required to gain access.
What should manufacturers do in using this guidance?
Use the following modified statement of compliance on the certification label: “Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated (Insert date of this guidance.)” or “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007”; and
Submit product reports or supplemental reports to describe changes to products in accordance with this guidance.
Laser Notice 56 (Dated May 8, 2019)
Example: Laser Notice 56
For laser products that are also considered a medical device:
“Complies with FDA performance standards for laser products except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in Laser Notice No. 56, dated May 8, 2019.” or
“Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in Laser Notice No. 56, dated May 8, 2019.”
For laser products that are not considered a medical device:
“Complies with FDA performance standards for laser products except for conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.” or
“Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.”
（3）関連箇所の参考和訳 (CFR 1040.10 and 1040.11)
FDA eventually intends to amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC because FDA acknowledges the advantages of one set of criteria and requirements worldwide.
Until these requirements are harmonized, for laser product manufacturers that comply with the comparable clauses in IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in this document, FDA does not intend to enforce the comparable requirements in 21 CFR 1040.10 and 21 CFR 1040.11.
This guidance announces that if the laser product conforms to the clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 identified in Section III as comparable with 21 CFR 1040.10 and 1040.11, FDA does not intend to enforce applicable FDA requirements. For example, FDA does not intend to enforce requirements relating to obtaining variances for laser products that conform to the relevant portions of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 identified as comparable with 21 CFR 1040.10 and 1040.11 as described in Section III below.
By the end of 2024, the U.S. Food and Drug Administration (FDA) intends to withdraw Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
This change is because newer International Electrotechnical Commission (IEC) standards have been issued.
This announcement ensures stakeholders have time to transition to Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).
機械規則は、必須健康安全要求(EHSR)に関する適合性の情報を要求している。
*EHS: Essential Health & Safety Regulations
機械規則は、継続生産のための安全品質維持プロセス(システム)の記載を要求している。
(1) 機械規則（Machinery Regulation 2023/1230）
REGULATIONS
REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1230
Technical documentation for machinery and related products. The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the machinery or related product with the applicable essential health and safety requirements set out in Annex III.
0 一般原則 1 必須健康安全要求事項 1.1 一般的事項 General remarks
1.1.1 適用 Applicability
1.1.2 安全性実現の原則 Principles of safety integration
1.1.3 素材と生産物 Materials and products
1.1.4 照明 Lighting
1.1.5 取り扱いを容易にするための機械類や関連製品の設計 Design of machinery or a related product to facilitate its handling
1.1.6 エルゴノミクス Ergonomics
1.1.7 操作位置 Operating positions
1.1.8 座席 Seating
1.1.9 不正行為に対する保護 Protection against corruption
1.2 制御システム Control systems
1.2.1 制御システムの安全性と信頼性 Safety and reliability of control systems
1.2.2 制御デバイス Control devices
1.2.3 始動 Starting
1.2.4 停止 Stopping
1.2.4.1 通常停止 Normal Stop
1.2.4.2 制御停止 Operational Stop
1.2.4.3 緊急停止 Emergency Stop
1.2.4.4 機械類や関連製品の組み立て Assembly of machinery or related products
1.2.5 制御/動作モードの選択 Selection of control or operating modes
1.2.6 電源や通信網接続の障害 Failure of the power supply or communication network connection
1.3 機械的なリスクに対する保護 Protection against mechanical risks
1.3.1 安定性の喪失に伴うリスク Risk of loss of stability
1.3.2 動作中の分解のリスク Risk of break-up during operation
1.3.3 物体の落下や放出に伴うリスク Risks due to falling or ejected objects
1.3.4 表面、エッジ、及び角に伴うリスク Risks due to surfaces, edges or angles
1.3.5 機械類や関連製品の組み合わせに関連するリスク Risks related to a combined machinery or related product
1.3.6 動作条件の変化に関係するリスク Risks related to variations in operating conditions
1.3.7 可動部に関連するリスク Risks related to moving parts
1.3.8 可動部から生じるリスクに対する保護の選択 Choice of protection against risks arising from moving parts
1.3.8.1 可動式動力伝達部 Moving transmission parts
1.3.8.2 工程に関係する可動部 Moving parts involved in the process
1.3.9 制御されない動きのリスク Risks of uncontrolled movements
1.4 ガードと保護デバイスの必要な特性 Required characteristics of guards and protective devices
1.4.1 一般的要求事項 General requirements
1.4.2 ガードに関する特別な要求事項 Special requirements for guards
1.4.2.1 固定ガード Fixed guards
1.4.2.2 インターロックされた可動ガード Interlock movable guards
1.4.2.3 アクセスを制限する調整可能ガード Adjustable guards restricting access
1.4.3 保護デバイスに対する特別な要求事項 Special requirements for protective devices
1.5 他の原因に伴うリスク Risks due to other causes
1.5.1 電源 Electricity supply
1.5.2 静電気 Static electricity
1.5.3 電力以外のエネルギー源 Energy supply other than electricity
1.5.4 取り付けの誤り Errors of fitting
1.5.5 極端な温度 Extreme temperatures
1.5.6 発火 Fire
1.5.7 爆発 Explosion
1.5.8 騒音 Noise
1.5.9 振動 Vibrations
1.5.10 放射 Radiation
1.5.11 外部の放射 External radiation
1.5.12 レーザー放射 Laser radiation
1.5.13 危険な素材や物質のエミッション Emissions of hazardous materials and substances
1.5.14 機械への閉じ込めのリスク Risk of being trapped in a machine
1.5.15 滑り、躓き、あるいは落下のリスク Risk of slipping, tripping or falling
1.5.16 雷 Lightning
1.6 保守 Maintenance
1.6.1 機械類や関連製品の保守 Machinery or related product maintenance
1.6.2 操作箇所と保守箇所へのアクセス Access to operating positions and servicing points
1.6.3 エネルギー源の切り離し Isolation of energy sources
1.6.4 オペレータの介入 Operator intervention
1.6.5 内部の清掃 Cleaning of internal parts
1.7 情報 Information
1.7.1 機械類や関連製品上の情報と警告 Information and warnings on the machinery or related product
1.7.1.1 情報と情報デバイス Information and information devices
1.7.1.2 警告デバイス Waring devices
1.7.2 残留リスクの警告 Warning of residual risks
1.7.3 機械類や関連製品のマーキング Marking of machinery or related products
1.7.4 使用指示書 Instructions for use
1.7.4.1 使用指示書の作成の一般原則 General principles for the drafting of instructions for use
1.7.4.2 使用指示書の内容 Contents of the instructions for use
1.7.5 販売用資料 Sales literature
Other risks related to new digital technologies are those provoked by malicious third parties that have an impact on the safety of products within the scope of this Regulation.
In this respect, manufacturers should be required to adopt proportionate measures which are limited to the protection of the safety of the product within the scope of this Regulation.
This does not preclude the application to products within the scope of this Regulation of other Union legal acts specifically addressing cybersecurity aspects.
With a view to addressing the risks stemming from malicious third party actions that have an impact on the safety of products within the scope of this Regulation, this Regulation should include essential health and safety requirements in respect of which conformity to the appropriate extent can be presumed as the result of a certificate or statement of conformity issued under a relevant cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 of the European Parliament and of the Council ( 15 ).
Machinery and related products that have been certified or for which a statement of conformity has been issued under a cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1, as regards protection against corruption and safety and reliability of control systems insofar as those requirements are covered by the cybersecurity certificate or statement of conformity or parts thereof.
The machinery or related product shall be designed and constructed so that the connection to it of another device, via any feature of the connected device itself or via any remote device that communicates with the machinery or related product does not lead to a hazardous situation. EN 29.6.2023 Official Journal of the European Union L 165/47
A hardware component transmitting signal or data, relevant for connection or access to software that is critical for the compliance of the machinery or related product with the relevant essential health and safety requirements shall be designed so that it is adequately protected against accidental or intentional corruption.
The machinery or related product shall collect evidence of a legitimate or illegitimate intervention in that hardware component, when relevant for connection or access to software that is critical for the compliance of the machinery or related product.
Software and data that are critical for the compliance of the machinery or related product with the relevant essential health and safety requirements shall be identified as such and shall be adequately protected against accidental or intentional corruption.
The machinery or related product shall identify the software installed on it that is necessary for it to operate safely, and shall be able to provide that information at all times in an easily accessible form.
The machinery or related product shall collect evidence of a legitimate or illegitimate intervention in the software or a modification of the software installed on the machinery or related product or its configuration.
独立して市場に出される安全機能を満足するように設計もしくは、意図されたその故障や誤動作が人の安全を危険に曝すが、その製品の機能のために必要ではない、あるいは、通常のコンポーネントと置き換えても製品が機能する、この規則の適用範囲内の製品のソフトウェアを含む物理的、あるいはデジタル・コンポーネントが対象となる。安全機能(safety function)は、その故障がリスクの増大をもたらし得るリスクの除去、あるいは、それが可能でない場合は、その低減のために設計された保護方策を満足させるための機能を意味する。
機械規則で言うところの安全コンポーネントは機械規則のAnnex II にリストされている。
’safety component’ means a physical or digital component, including software, of a product within the scope of this Regulation, which is designed or intended to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endanger the safety of persons, but which is not necessary in order for that product to function or for which normal components may be substituted in order for that product to function.
With a view to addressing the risks stemming from malicious third party actions that have an impact on the safety of products within the scope of this Regulation, this Regulation should include essential health and safety requirements in respect of which conformity to the appropriate extent can be presumed as the result of a certificate or statement of conformity issued under a relevant cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 of the European Parliament and of the Council.
(5) 無線機器指令(RED)のサイバーセキュリティ規格 (EN 18031 Series：2024年8月14日発行)
EN 18031-1:2024 Common security requirements for radio equipment - Part 1: Internet connected radio equipment 無線機器指令 第3条(3) (d)の要求事項に対応
EN 18031-2:2024 Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment 無線機器指令 第3条(3) (e)の要求事項に対応
EN 18031-3:2024 Common security requirements for radio equipment - Part 3: Internet connected radio equipment processing virtual money or monetary value 無線機器指令 第3条(3) (f)の要求事項に対応
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