ISO 12100:2010 機械の安全性—設計の一般原則—リスク評価とリスク低減

この規格プレビューページの目次

※一部、英文及び仏文を自動翻訳した日本語訳を使用しています。

3 用語と定義

この文書の目的上、次の用語と定義が適用されます。

3.1

機械

少なくとも 1 つが可動し、特定の用途に合わせて結合される、リンクされた部品またはコンポーネントで構成される駆動システムが取り付けられている、または取り付けられることが意図されているアセンブリ。

注記 1: 「機械」という用語には、同じ目的を達成するために、一体として機能するように配置され、制御される機械の集合体も含まれます。

注記 2: 附属書 A には、機械の一般的な概略図が記載されています。

3.2

信頼性

機械、そのコンポーネント、または装置が、指定された条件下で、指定された期間、故障することなく必要な機能を実行する能力

3.3

保守性

指定された慣行に従って、指定された手段を使用して必要な処置（保守）が実行されることにより、機械が意図された使用条件下でその機能を果たすことを可能にする状態に維持される、またはそのような状態に復元される機械の能力

3.4

使いやすさ

とりわけ、その機能を容易に理解できるようにする特性または特性により、機械が容易に使用できる能力。

3.5

危害

身体的損傷または健康被害

3.6

危険

潜在的な危害源

注記 1: 「危険」という用語は、その起源 (例えば、機械的危険、電気的危険) または潜在的な危害の性質 (例えば、感電の危険、切断の危険、有毒な危険、火災の危険）。

注記 2:この定義によって想定される危険は、次のいずれかです。

機械の意図された使用中に永続的に存在するもの (たとえば、危険な可動要素の動き、溶接段階中の電気アーク、不健康な姿勢、騒音の放出、高温)、または
予期せぬ事態が発生する可能性があります（たとえば、爆発、意図しない/予期せぬ始動の結果としての圧壊の危険、破損の結果としての放出、加速/減速の結果としての落下）。

注記 3:フランス語の用語「フェノメーヌ・デンジャー」を、過去に代わりに使用されることもあった「きわどい」という用語と混同してはならない。

3.7

参考文献

1	ISO/IEC Guide 51, 安全面 - 規格に含めるためのガイドライン
2	ISO 447, 工作機械 - 制御装置の動作方向
3	ISO 2972、機械の数値制御 - 記号
4	ISO 4413, 油圧流体動力 - システムに関する一般規則
5	ISO 4414, 空気圧流体動力 - システムに関する一般規則
6	ISO 6385, 作業システム設計における人間工学的原則
7	ISO 7000, 機器で使用する図記号 — 索引と概要
8	ISO 9355-1, ディスプレイおよび制御アクチュエーターの設計に関する人間工学的要件 — Part 1: ディスプレイおよび制御アクチュエーターとの人間の相互作用
9	ISO 9355-3, ディスプレイおよび制御アクチュエーターの設計に関する人間工学的要件 — Part 3: 制御アクチュエーター
10	ISO 10075, 精神的作業負荷に関する人間工学的原則 — 一般用語と定義
11	ISO 10075-2, 精神的負荷に関連する人間工学的原則 — Part 2: 設計原則
12	ISO/TR 11688-1, 音響 — 低騒音の機械および装置の設計に推奨される実践 — Part 1: 計画
13	ISO 11689, 音響 - 機械および装置の騒音放出データの比較手順
14	ISO 13849-1:2006, 機械の安全性 — 制御システムの安全関連部分 — Part 1: 設計の一般原則
15	ISO 13850, 機械の安全性 - 非常停止 - 設計原則
16	ISO 13851, 機械の安全性 — 両手制御装置 — 機能的側面と設計原則
17	ISO 13854, 機械の安全性 - 人体の一部の衝突を避けるための最小限の隙間
18	ISO 13855, 機械の安全性 - 人体の各部分への接近速度に関する保護具の位置
19	ISO 1385, 機械の安全性 - 感圧保護装置
20	ISO 13857, 機械の安全性 — 上肢と下肢が危険ゾーンに到達するのを防ぐための安全距離
21	ISO 14118:2000, 機械の安全性 - 予期せぬ始動の防止
22	ISO 14119, 機械の安全性 - ガードに関連するインターロック装置 - 設計と選択の原則
23	ISO 14120:2002, 機械の安全性 — ガード — 固定および可動ガードの設計および構造に関する一般要件
24	ISO/TR 14121-2, 機械の安全性 — リスク評価 — Part 2: 実践的なガイダンスと方法の例
25	ISO 1412, 機械の安全性 - 機械への恒久的なアクセス手段
26	ISO 14122-3, 機械の安全性 — 機械への恒久的なアクセス手段 — Part 3: 階段、脚立、ガードレール
27	ISO 14123-1, 機械の安全性 — 機械から放出される有害物質による健康へのリスクの軽減 — Part 1: 機械製造業者のための原則と仕様
28	ISO 14163, 音響 — サイレンサーによる騒音制御のガイドライン
29	ISO 15667, 音響 — エンクロージャーおよびキャビンによる騒音制御のガイドライン
30	IEC 60079-11, 爆発性雰囲気 - Part 11: 本質安全防爆「i」による機器保護
31	IEC 6020, 機械の安全性 - 機械の電気機器
32	IEC 60335-1, 家庭用および類似の電気機器 - 安全性 - Part 1: 一般要件
33	IEC 60745-1, 手持ち式電動電動工具 - Part 1: 一般要件
34	IEC 60947-5-1, 低電圧開閉装置および制御装置 — Part 5-1: 制御回路デバイスおよびスイッチング素子 — 電気機械制御回路装置
35	IEC 61000-, 電磁両立性 (EMC) — Part 6: 一般規格
36	IEC 6102, 可搬式電動工具の安全性
37	IEC 6131, 機械の安全性 - 表示、マーキングおよび作動
38	IEC 6149, 機械の安全性 — 電気感応性保護装置
39	IEC 6150, 電気/電子/プログラム可能な電子安全関連システムの機能安全
40	IEC/TS 62046, 機械の安全性 - 人の存在を検出するための保護装置の適用
41	IEC 62061, 機械の安全性 - 安全関連の電気、電子、およびプログラマブル電子制御システムの機能安全
42	IEC 62079, 指示の作成 - 構造、内容、および表示
43	IEV 191 については、IEC 60050-191, International Electrotechnical Vocabulary — 第 191 章: 信頼性とサービス品質を参照してください。
44	CR 1030-1, ハンドアームの振動 — 振動の危険を軽減するためのガイドライン — Part 1: 機械の設計によるエンジニアリング方法
45	EN 614-1, 機械の安全性 — 人間工学に基づいた設計原則 — Part 1: 用語と一般原則
46	EN 1299, 機械的振動と衝撃 — 機械の振動絶縁 — 発生源絶縁の適用に関する情報
47	EN 12198-1, 機械の安全性 — 機械から放出される放射線から生じるリスクの評価と軽減 — Part 1: 一般原則
48	EN 12198-3, 機械の安全性 — 機械から放出される放射線から生じるリスクの評価と軽減 — Part 3: 減衰またはスクリーニングによる放射線の低減
49	EN 13861, 機械の安全性 — 機械の設計における人間工学規格の適用に関するガイダンス

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1

machinery

machine

assembly, fitted with or intended to be fitted with a drive system consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application

Note 1 to entry: The term “machinery” also covers an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole.

Note 2 to entry: Annex A provides a general schematic representation of a machine.

3.2

reliability

ability of a machine or its components or equipment to perform a required function under specified conditions and for a given period of time without failing

3.3

maintainability

ability of a machine to be maintained in a state which enables it to fulfil its function under conditions of intended use, or to be restored to such a state, with the necessary actions (maintenance) being carried out according to specified practices and using specified means

3.4

usability

ability of a machine to be easily used owing to, among others, properties or characteristics that enable its function(s) to be easily understood

3.5

harm

physical injury or damage to health

3.6

hazard

potential source of harm

Note 1 to entry: The term “hazard” can be qualified in order to define its origin (for example, mechanical hazard, electrical hazard) or the nature of the potential harm (for example, electric shock hazard, cutting hazard, toxic hazard, fire hazard).

Note 2 to entry: The hazard envisaged by this definition either

is permanently present during the intended use of the machine (for example, motion of hazardous moving elements, electric arc during a welding phase, unhealthy posture, noise emission, high temperature), or
can appear unexpectedly (for example, explosion, crushing hazard as a consequence of an unintended/unexpected start-up, ejection as a consequence of a breakage, fall as a consequence of acceleration/deceleration).

Note 3 to entry: The French term “phénomène dangereux” should not be confused with the term “risque”, which was sometimes used instead in the past.

3.7

relevant hazard

hazard which is identified as being present at, or associated with, the machine

Note 1 to entry: A relevant hazard is identified as the result of one step of the process described in Clause 5.

Note 2 to entry: This term is included as basic terminology for type-B and type-C standards.

3.8

significant hazard

hazard which has been identified as relevant and which requires specific action by the designer to eliminate or to reduce the risk according to the risk assessment

Note 1 to entry: This term is included as basic terminology for type-B and type-C standards.

3.9

hazardous event

event that can cause harm

Note 1 to entry: A hazardous event can occur over a short period of time or over an extended period of time.

3.10

hazardous situation

circumstance in which a person is exposed to at least one hazard

Note 1 to entry: The exposure can result in harm immediately or over a period of time.

3.11

hazard zone

danger zone

any space within and/or around machinery in which a person can be exposed to a hazard

3.12

risk

combination of the probability of occurrence of harm and the severity of that harm

3.13

residual risk

risk remaining after protective measures have been implemented

Note 1 to entry: This International Standard distinguishes

the residual risk after protective measures have been implemented by the designer,
the residual risk remaining after all protective measures have been implemented.

3.14

risk estimation

defining likely severity of harm and probability of its occurrence

3.15

risk analysis

combination of the specification of the limits of the machine, hazard identification and risk estimation

3.16

risk evaluation

judgment, on the basis of risk analysis, of whether the risk reduction objectives have been achieved

3.17

risk assessment

overall process comprising a risk analysis and a risk evaluation

3.18

adequate risk reduction

risk reduction that is at least in accordance with legal requirements, taking into consideration the current state of the art

Note 1 to entry: Criteria for determining when adequate risk reduction is achieved are given in 5.6.2.

3.19

protective measure

measure intended to achieve risk reduction, implemented

by the designer (inherently safe design, safeguarding and complementary protective measures, information for use) and/or
by the user (organization: safe working procedures, supervision, permit-to-work systems; provision and use of additional safeguards; use of personal protective equipment; training)

3.20

inherently safe design measure

protective measure which either eliminates hazards or reduces the risks associated with hazards by changing the design or operating characteristics of the machine without the use of guards or protective devices

3.21

safeguarding

protective measure using safeguards to protect persons from the hazards which cannot reasonably be eliminated or risks which cannot be sufficiently reduced by inherently safe design measures

3.22

information for use

protective measure consisting of communication links (for example, text, words, signs, signals, symbols, diagrams) used separately or in combination, to convey information to the user

3.23

intended use

use of a machine in accordance with the information for use provided in the instructions

3.24

reasonably foreseeable misuse

use of a machine in a way not intended by the designer, but which can result from readily predictable human behaviour

3.25

task

specific activity performed by one or more persons on, or in the vicinity of, the machine during its life cycle

3.26

safeguard

guard or protective device

3.27

guard

physical barrier, designed as part of the machine to provide protection

Note 1 to entry: A guard may act either

alone, in which case it is only effective when “closed” (for a movable guard) or “securely held in place” (for a fixed guard), or
conjunction with an interlocking device with or without guard locking, in which case protection is ensured whatever the position of the guard.

Note 2 to entry: Depending on its construction, a guard may be described as, for example, casing, shield, cover, screen, door, enclosing guard.

Note 3 to entry: The terms for types of guards are defined in 3.27.1 to 3.27.6. See also 6.3.3.2 and ISO 14120 for types of guards and their requirements.

3.27.1

fixed guard

guard affixed in such a manner (for example, by screws, nuts, welding) that it can only be opened or removed by the use of tools or by destruction of the affixing means

3.27.2

movable guard

guard which can be opened without the use of tools

3.27.3

adjustable guard

fixed or movable guard which is adjustable as a whole or which incorporates adjustable part(s)

3.27.4

interlocking guard

guard associated with an interlocking device so that, together with the control system of the machine, the following functions are performed:

the hazardous machine functions “covered” by the guard cannot operate until the guard is closed,
if the guard is opened while hazardous machine functions are operating, a stop command is given, and
when the guard is closed, the hazardous machine functions “covered” by the guard can operate (the closure of the guard does not by itself start the hazardous machine functions)

Note 1 to entry: ISO 14119 gives detailed provisions.

3.27.5

interlocking guard with guard locking

guard associated with an interlocking device and a guard locking device so that, together with the control system of the machine, the following functions are performed:

the hazardous machine functions “covered” by the guard cannot operate until the guard is closed and locked,
the guard remains closed and locked until the risk due to the hazardous machine functions “covered” by the guard has disappeared, and
when the guard is closed and locked, the hazardous machine functions “covered” by the guard can operate (the closure and locking of the guard do not by themselves start the hazardous machine functions)

Note 1 to entry: ISO 14119 gives detailed provisions.

3.27.6

interlocking guard with a start function

control guard

special form of interlocking guard which, once it has reached its closed position, gives a command to initiate the hazardous machine function(s) without the use of a separate start control

Note 1 to entry: See 6.3.3.2.5 for detailed provisions on the conditions of use.

3.28

protective device

safeguard other than a guard

Note 1 to entry: Examples of types of protective devices are 3.28.1 to 3.28.9.

3.28.1

interlocking device

interlock

mechanical, electrical or other type of device, the purpose of which is to prevent the operation of hazardous machine functions under specified conditions (generally as long as a guard is not closed)

3.28.2

enabling device

additional manually operated device used in conjunction with a start control and which, when continuously actuated, allows a machine to function

3.28.3

hold-to-run control device

control device which initiates and maintains machine functions only as long as the manual control (actuator) is actuated

3.28.4

two-hand control device

control device which requires at least simultaneous actuation by both hands in order to initiate and to maintain hazardous machine functions, thus providing a protective measure only for the person who actuates it

Note 1 to entry: ISO 13851 gives detailed provisions.

3.28.5

sensitive protective equipment

SPE

equipment for detecting persons or parts of persons which generates an appropriate signal to the control system to reduce risk to the persons detected

Note 1 to entry: The signal can be generated when a person or part of a person goes beyond a predetermined limit — for example, enters a hazard zone — (tripping) or when a person is detected in a predetermined zone (presence sensing), or in both cases.

3.28.6

active optoelectronic protective device

AOPD

device whose sensing function is performed by optoelectronic emitting and receiving elements detecting the interruption of optical radiation, generated within the device, by an opaque object present in the specified detection zone

Note 1 to entry: IEC 61496 gives detailed provisions.

3.28.7

mechanical restraint device

device which introduces into a mechanism a mechanical obstacle (for example, wedge, spindle, strut, scotch) which, by virtue of its own strength, can prevent any hazardous movement

3.28.8

limiting device

device which prevents a machine or hazardous machine condition(s) from exceeding a designed limit (space limit, pressure limit, load moment limit, etc.)

3.28.9

limited movement control device

control device, a single actuation of which, together with the control system of the machine, permits only a limited amount of travel of a machine element

3.29

impeding device

any physical obstacle (low barrier, rail, etc.) which, without totally preventing access to a hazard zone, reduces the probability of access to this zone by offering an obstruction to free access

3.30

safety function

function of a machine whose failure can result in an immediate increase of the risk(s)

3.31

unexpected start-up

unintended start-up

any start-up which, because of its unexpected nature, generates a risk to persons

Note 1 to entry: This can be caused by, for example:

a start command which is the result of a failure in, or an external influence on, the control system;
a start command generated by inopportune action on a start control or other parts of the machine such as a sensor or a power control element;
restoration of the power supply after an interruption;
external/internal influences (gravity, wind, self-ignition in internal combustion engines, etc.) on parts of the machine.

Note 2 to entry: Machine start-up during normal sequence of an automatic cycle is not unintended, but can be considered as being unexpected from the point of view of the operator. Prevention of accidents in this case involves the use of safeguarding measures (see 6.3).

Note 3 to entry: Adapted from ISO 14118:2000, definition 3.2.

3.32

failure to danger

any malfunction in the machinery, or in its power supply, that increases the risk

3.33

fault

state of an item characterized by inability to perform a required function, excluding the inability during preventive maintenance or other planned actions, or due to lack of external resources

[SOURCE:IEV 191-05-01]

Note 1 to entry: A fault is often the result of a failure of the item itself, but can exist without prior failure.

Note 2 to entry: In the field of machinery, the English term “fault” is commonly used in accordance with the definition in IEV 191-05-01, whereas the French term “défaut” and the German term “Fehler” are used rather than the terms “panne” and “Fehlzustand” that appear in the IEV with this definition.

Note 3 to entry: In practice, the terms “fault” and “failure” are often used synonymously.

3.34

failure

termination of the ability of an item to perform a required function

Note 1 to entry: After failure, the item has a fault.

Note 2 to entry: “Failure” is an event, as distinguished from “fault”, which is a state.

Note 3 to entry: The concept as defined does not apply to items consisting of software only.

[SOURCE:IEV 191-04-01]

3.35

common cause failures

failures of different items, resulting from a single event ここで, these failures are not consequences of each other

Note 1 to entry: Common cause failures should not be confused with common mode failures.

[SOURCE:IEV 191-04-23]

3.36

common mode failures

failures of items characterized by the same fault mode

Note 1 to entry: Common mode failures should not be confused with common cause failures, as the common mode failures can result from different causes.

[SOURCE:IEV 191-04-24]

3.37

malfunction

failure of a machine to perform an intended function

Note 1 to entry: See 5.4, item b) 2) for examples.

3.38

emergency situation

hazardous situation needing to be urgently ended or averted

Note 1 to entry: An emergency situation can arise

during normal operation of the machine (for example, due to human interaction, or as a result of external influences), or
as a consequence of a malfunction or failure of any part of the machine.

3.39

emergency operation

all actions and functions intended to end or avert an emergency situation

3.40

emergency stop

emergency stop function

function which is intended to

avert arising or reduce existing hazards to persons, damage to machinery or to work in progress, and
be initiated by a single human action

Note 1 to entry: ISO 13850 gives detailed provisions.

3.41

emission value

numerical value quantifying an emission generated by a machine (for example, noise, vibration, hazardous substances, radiation)

Note 1 to entry: Emission values are part of the information on the properties of a machine and are used as a basis for risk assessment.

Note 2 to entry: The term “emission value” ought not to be confused with “exposure value”, which quantifies the exposure of persons to emissions when the machine is in use. Exposure values can be estimated using the emission values.

Note 3 to entry: Emission values are preferably measured and their associated uncertainties determined by means of standardized methods (for example, to allow comparison between similar machines).

3.42

comparative emission data

set of emission values of similar machines collected for the purpose of comparison

Note 1 to entry: For noise comparison, see ISO 11689.

Bibliography

1	ISO/IEC Guide 51, Safety aspects — Guidelines for their inclusion in standards
2	ISO 447, Machine tools — Direction of operation of controls
3	ISO 2972, Numerical control of machines — Symbols
4	ISO 4413, Hydraulic fluid power — General rules relating to systems
5	ISO 4414, Pneumatic fluid power — General rules relating to systems
6	ISO 6385, Ergonomic principles in the design of work systems
7	ISO 7000, Graphical symbols for use on equipment — Index and synopsis
8	ISO 9355-1, Ergonomic requirements for the design of displays and control actuators — Part 1: Human interactions with displays and control actuators
9	ISO 9355-3, Ergonomic requirements for the design of displays and control actuators — Part 3: Control actuators
10	ISO 10075, Ergonomic principles related to mental work-load — General terms and definitions
11	ISO 10075-2, Ergonomic principles related to mental workload — Part 2: Design principles
12	ISO/TR 11688-1, Acoustics — Recommended practice for the design of low-noise machinery and equipment — Part 1: Planning
13	ISO 11689, Acoustics — Procedure for the comparison of noise-emission data for machinery and equipment
14	ISO 13849-1:2006, Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design
15	ISO 13850, Safety of machinery — Emergency stop — Principles for design
16	ISO 13851, Safety of machinery — Two-hand control devices — Functional aspects and design principles
17	ISO 13854, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
18	ISO 13855, Safety of machinery — Positioning of protective equipment with respect to the approach speeds of parts of the human body
19	ISO 13856 (all parts), Safety of machinery — Pressure-sensitive protective devices
20	ISO 13857, Safety of machinery — Safety distances to prevent hazard zones being reached by upper and lower limbs
21	ISO 14118:2000, Safety of machinery — Prevention of unexpected start-up
22	ISO 14119, Safety of machinery — Interlocking devices associated with guards — Principles for design and selection
23	ISO 14120:2002, Safety of machinery — Guards — General requirements for the design and construction of fixed and movable guards
24	ISO/TR 14121-2, Safety of machinery — Risk assessment — Part 2: Practical guidance and examples of methods
25	ISO 14122 (all parts), Safety of machinery — Permanent means of access to machinery
26	ISO 14122-3, Safety of machinery — Permanent means of access to machinery — Part 3: Stairs, stepladders and guard-rails
27	ISO 14123-1, Safety of machinery — Reduction of risks to health from hazardous substances emitted by machinery — Part 1: Principles and specifications for machinery manufacturers
28	ISO 14163, Acoustics — Guidelines for noise control by silencers
29	ISO 15667, Acoustics — Guidelines for noise control by enclosures and cabins
30	IEC 60079-11, Explosive atmospheres — Part 11: Equipment protection by intrinsic safety “i”
31	IEC 60204 (all parts), Safety of machinery — Electrical equipment of machines
32	IEC 60335-1, Household and similar electrical appliances — Safety — Part 1: General requirements
33	IEC 60745-1, Hand-held motor-operated electric tools — Part 1: General requirements
34	IEC 60947-5-1, Low-voltage switchgear and controlgear — Part 5-1: Control circuit devices and switching elements — Electromechanical control circuit devices
35	IEC 61000-6 (all parts), Electromagnetic compatibility (EMC) — Part 6: Generic standards
36	IEC 61029 (all parts), Safety of transportable motor-operated electric tools
37	IEC 61310 (all parts), Safety of machinery — Indication, marking and actuation
38	IEC 61496 (all parts), Safety of machinery — Electro-sensitive protective equipment
39	IEC 61508 (all parts), Functional safety of electrical/electronic/programmable electronic safety-related systems
40	IEC/TS 62046, Safety of machinery — Application of protective equipment to detect the presence of persons
41	IEC 62061, Safety of machinery — Functional safety of safety-related electrical, electronic and programmable electronic control systems
42	IEC 62079, Preparation of instructions — Structuring, content and presentation
43	IEV 191 see IEC 60050-191, International Electrotechnical Vocabulary — Chapter 191: Dependability and quality of service
44	CR 1030-1, Hand-arm vibration — Guidelines for vibration hazards reduction — Part 1: Engineering methods by design of machinery
45	EN 614-1, Safety of machinery — Ergonomic design principles — Part 1: Terminology and general principles
46	EN 1299, Mechanical vibration and shock — Vibration isolation of machines — Information for the application of source isolation
47	EN 12198-1, Safety of machinery — Assessment and reduction of risks arising from radiation emitted by machinery — Part 1: General principles
48	EN 12198-3, Safety of machinery — Assessment and reduction of risks arising from radiation emitted by machinery — Part 3: Reduction of radiation by attenuation or screening
49	EN 13861, Safety of machinery — Guidance for the application of ergonomics standards in the design of machinery

ISO 12100:2010 機械の安全性—設計の一般原則—リスク評価とリスク低減 | ページ 6

3 用語と定義

参考文献

3 Terms and definitions

Bibliography

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