標準(Standards):
2010 年 10 月 20 日國際標準化組織(ISO)第 188 號技術委員會 (ISO/TC 199)「機械安全性」(ISO/TC 199: Safety of Machinery),發行改版的 ISO 12100:2010《機械安全性 - 一般設計原則 - 風險評鑑與風險降低》(Safety of Machinery - General Priciples for Design - Risk Assessment and Risk Reduction),此一標準的內容併入 ISO 12100 的兩份增補文件,ISO 12100-1/Amd.1:2009、ISO 12100-2/Amd.2:2009,同時取銷三份使用很長一段時間的機械安全性標準:ISO 12100-1:2003《機械安全性 - 基本概念、一般設計原理 - 第 1 部:基本名詞、方法》(ISO 12100-1:2003, Safety of Machinery - Basic Concepts, General Principles for Design - Part 1: Basic Terminoloty, Mehodology)、ISO 12100-2:2007《機械安全性 - 基本概念、一般設計原理 - 第 2 部:技術原理》(ISO 12100-2:2007, Safety of Machinery - Basic Concepts, General Principles for Design - Part 2: Technical Principles)、及ISO 14121-1:2007《機械安全性 - 風險評鑑 - 第 1 部:原理》(ISO 14121-1:2007, Safety of Machinery - Risk Assessment - Part 1: Principles),三份標準變成一份標準,保留 ISO/TR 14121-2:2007 作為風險評鑑的指導綱要及提供各種機械風險評估範例。
1. 安全性議題:ISO/IEC Guide 51
ISO/IEC Guide 51《標準包含安全性方面議題之指導綱要》有句話值得省思:品質與安全性不是同義字,因此品質與安全性相對應所產生的職務不應該混淆。(Quality is not a synonym for safety and consequently the respective roles of quality and of safety should not be confused. )
Guide 51 說明,國際標準組織 (ISO) 對「標準 (standards)」的定義包括其所出版的國際標準 (international standards, IS)、技術規格 (technical specifications, TS)、公共可用規格 (publicly available specifications, PAS)、及指南 (guides)。
Guide 51 第 7.1 節「安全性標準類別」,將安全性標準架構分為:
基本安全性標準 (basic safety standard),又稱為 A 類安全性標準:例如:ISO 12100、ISO 14121。(basic safety standard, comprising fundamental concepts, principles and requirements with regard to general safety aspects applicable to a wide range of products and systems;)
群組安全性標準 (group safety standard),又稱為 B 類安全性標準:例如:ISO 13849、ISO 14119、IEC 60204。(group safety standard, comprising safety aspects applicable to serveral or a family of similar products or systems dealt with by more than one committee, making reference, as far as possible, to basic safety standards;)
產品安全性標準 (product safety standard),又稱為 C 類安全性標準。(product safety standard, comprising aspect(s) for a specific, or a family of, product(s) or sysems within the scope of a signle committee, making reference, as far as possible, to basic safety standard and group safety standards;)
包含安全性方面議題之安全性標準 (safety standard containing safety aspects):不完全只是討論安全性議題的安全性標準。(safety standards containing safety aspects but which do not deal exclusively with safety aspects; these should make reference as far as possible to basic safety standards and group safety standards.)
2. ISO 12100:2010
2010 年國際標準化組織 (ISO) 公布 ISO 12100:2010《機械安全性 - 設計用一般原則 - 風險評鑑和風險降低》( Safety of machinery -- General principles for design - Risk assessment and risk reduction)。
ISO 12100:2010 可保護機械操作者、幫助機械設計師和製造商降低安全危害。無論是人員、經濟和社會方面,涉及機械的事故通常會付出高額的成本。雖然計算一個精確的金額是不切實際的,但是最近的研究顯示,一個單一事故的總花費對於個人和社會可以高達 100 萬美元。ISO 12100 標準可幫助設計人員在機器生產的設計階段中就能夠識別風險,從而降低未來事故發生的機率。
ISO 12100:2010 所提供的風險評鑑指導方針呈現一系列的邏輯步驟。這將幫助設計人員有系統地決定機器的極限,識別風險危害,如:軋碎、切割、電擊(觸電)或機械疲勞;並且估計從機器故障至人為錯誤所引發的潛在危險。此外,還可以幫助生產者確定機器是否安全,不夠安全的話,再進行重新加工生產,一直重複到機器被確定為可以安全使用的。
發展 ISO 12100:2010 的 ISO 技術委員會主席克里斯托夫 (Christoph Preuße)說:「ISO 12100 將會保護個人遠離傷害,在降低財政支出和人力成本的同時,也確保使用者擁有一個友善的工作環境。」
ISO 12100:2010 取代 ISO 12100-1:2003、ISO 12100-2:2003 和 ISO 14121-1:2007。
ISO 12100:2010 為 A 類機械安全標準(基本安全標準),其預定用途是作為 B 類規格(通用安全規格)或 C 類規格(個別產品安全規格)的基礎。
A 類標準「基本安全性標準」(basic safety standards),主要是解說基本概念,設計原則及一般層面加以規範之規格,大方向的標準,可適用於所有機器的一般情形。 (Type-A standards (basic safety standards) giving basic concepts, principles for design and general aspects that can be applied to machinery.)
B 類標準「通用安全性標準」(generic safety standards),主要是針對可以廣泛應用於多種機械的安全觀念或防護裝置而寫的標準。又可概分為 B1 及 B2 兩類: (Type-B standards (generic safety standards) dealing with one safety aspect or one type of safeguard that can be used across a wide range of machinery.)
B1 類標準:特定安全相關標準。(如:安全距離、表面溫度、噪音)(Type-B1 standards on particular safety aspects (for example, safety distances,surface temperature, noise).)
B2 類標準:關於安全防護標準。(如:雙手控制裝置、聯鎖裝置、壓力敏感裝置、防護等)(Type-B2 standards on safeguards (for example, two-hand controls, interlocking devices, pressure-sensitive devices, guards).)
C 類標準「機器安全性標準」(machine safety standards),係對於特定機器或機器群體之詳細安全要求事項加以規定。 (Type-C standards (machine safety standards) dealing with detailed safety requirements for a particular machine or group of machines.)
ISO 12100:2010 對於機械安全性標準的分類大致與 ISO/IEC Guide 51 相同,唯一不同是 B 類與 C 類標準的名稱,ISO 12100 稱 B 類標準為通用安全性標準(generic safety standards)、C 類標準為機器安全性標準(machine safety standards),而 ISO/IEC Guide 51 稱 B 類標準為群組安全性標準(group safety standards)、C 類標準為產品安全性標準(product safety standards)。
ISO/IEC Guide 51:1999, Safety Aspects - Guidelines for Their Inclusion in Standards
3.2 A 類基本安全性標準A 類安全性標準包括適用於各種產品與系統一般安全層面的相關基本概念、規則、與要求,常見的有:
ISO 12100:2010, 《機械安全性 - 一般設計原理 - 風險評鑑與風險降低》(Safety of Machinery - General Principles for Design - Risk Assessment and Risk Reduction) 。ISO 12100 的前身為 EN 292,2010年版的發行,撤消及取代 ISO 12100-1:2003、ISO 12100-2:2003、及ISO 14121-1:2007。
ISO 12100-1:2003+A1:2009, 《機械安全性 - 基本概念、一般設計原理 - 第1部:基本名詞、方法》(Safety of Machinery - Basic Concepts, General Principles for Design - Part 1: Basic Terminology, Methodology.)。2009年增訂版,已撤銷為2010年版所取代。
ISO 12100-1:2003, 《機械安全性 - 基本概念、一般設計原理 - 第1部:基本名詞、方法》(Safety of Machinery - Basic Concepts, General Principles for Design - Part 1: Basic Terminoloty, Methodology)。
ISO 12100-2:2003, 《機械安全性 - 基本概念、一般設計原理 - 第2部:技術原理》(Safety of Machinery - Basic Concepts, General Principles for Design - Part 2: Technical Principles)
ISO 14121-1:2007, 《機械安全性 - 風險評鑑 - 第1部:原理》(Safety of Machinery - Risk Assessment - Part 1: Principles)
ISO 14121-2:2007, 《機械安全性 - 風險評鑑 - 第2部:實務指引與方法範例》(Safety of Machinery - Risk Assessment - Part 2: Practical Guidance and Examples of Methods)。
ISO 61508 (series), 《電機電子與可程式電子安全性相關系統功能安全性》(Functional Safety of Electrical, Electronic, and Programmable Electronic Safety-Related Systems)。
3.3 B 類群組安全性標準
B 類群組安全性標準包括適用於各種產品或系統、或一系列類似產品或系統的安全層面,且盡可能參考基本安全性標準,常見的如:
ISO 13848, Safety Machinery - Terminology
ISO 13849-1, Safety of Machinery - Safety-Related Parts of Control System - Part 1: General Principles for Design
ISO 13849-2, Safety of Machinery - Safety-Related Parts of Control System - Part 2: Validation
ISO 13849-100, Safety of Machinery - Safety-Related Parts of Control System - Part 100: Guidelines for the Use and Application of ISO 13849-1
ISO 13850, 《機械安全性 - 緊急停機 - 設計原理》Safety of Machinery - Emergency Stop - Principles for Design
ISO 13851, Safety of Machinery - Two-Hand Control Devices - Functional Aspects and Design Principles
ISO 13852, Safety of Machinery - Safety Distances to Prevent Danger Zones being Reached by the Upper Limbs
ISO 13853, Safety of Machinery - Safety Distances to Prevent Danger Zones being Reached by the Lower Limbs
ISO 13854, Safety of Machinery - Minimum Gaps to Avoid Crushing of Parts of the Human Body
ISO 13855, Safety of Machinery - Positioning of Protective Equipment with respect to the Approach Speeds of Parts of the Human Body
ISO 13856-1, Safety of Machinery - Pressure-Sensitive Protective Devices - Part 1: General Principles for Design and Testing of Pressure-Sensitive Mats and Pressure-Sensitive Floors
ISO 13857, 《機械安全性 - 防止上肢與下肢接近危害區之安全性距離》(Safety of Machinery - Safety Distances to Prevent Hazard Zones being Reached by Upper and Lower Limbs. )。
ISO 14118, Safety of Machinery, Prevention of Unexpected Start-Up
ISO 14119, Safety of Machinery - Interlocking Devices Associated with Guards - Principles for Design and Selection
ISO 14120, Safety of Machinery - Guards - General Requirements for the Design and Construction of Fixed and Movable Guards
ISO 14122-1, Safety of Machinery - Permanent Means of Access to Machinery - Part 1: Choise of Fixed Means of Access between tow Levels
ISO 14122-2, Safety of Machinery - Permanent Means of Access to Machinery - Part 2: Working Platforms and Walkways
ISO 14122-3, Safety of Machinery - Permanent Means of Access to Machnery - Part 3: Stairs, Stepladders and Guard-Rails
ISO 14122-4, Safety of Machinery - Permanent Means of Access to Machinery - Part 4: Fixed Ladders
ISO 14123-1, Safety of Machinery - Reduction of Risks to Health from Hazardous Substances Emitted by Machniery - Part 1: Principles and Specifications for Machinery Manufacturers
ISO 14123-2, Safety of Machinery - Reduction of Risks to Health from Hazardous Substances Emitted by Machinery - Part 2: Methodology Leading to Verification Procedures
ISO 14159, Safety of Machinery - Hygiene Requirements for the Design of Machinery
IEC 60204-1:2006, Safety of Machinery - Electrical Equipment of Machines - Part 1: General Requirements
IEC 60204-11, Safety of Machinery - Electrical Equipment of Machines - Part 11: Requirements for HV Equipment for Voltage above 1,000 V a.c. or 1,500 V d.c. and not Exceeding 36 kV
IEC 60204-31, Safety of Machinery - Electrical Equipment of Machines - Part 31: Particular Safety and EMC Requirements for Sewing Machines, Units and Systems
IEC 60947 (series), Low-Voltage Switchgear and Controlgear
IEC 60204-32, Safety of Machinery - Electrical Equipment of Machines - Part 32: Requirements for Hoisting Machines
IEC 61310-1, Safety of Machinery - Indication, Marking and Actuation - Part 1: Requirements for Visual, Auditory and Tactile Signals
IEC 61310-2, Safety of Machinery - Indication, Marking and Actuation - Part 2: Requirements of Marking
IEC 61310-3, Safety of Machniery - Indication, Marking and Actuation - Part 3: Requirements for the Location and Operation of Actuators
IEC 61491, Electrical Equipment of Industrial Machines - Serial Data Link for Real-Time Communications between Control and Drives
IEC 61496-1, Safety of Machinery - Electrosensitive Protective Equipment - Part 1: General Requirements and Tests
IEC 61496-2, Safety of Machinery - Electro-sensitive Protective Equipment - Part 2: Particular Requirements for Equipment Using Active Opto-electronic Protective Devices (AOPDs)
IEC 61496-3, Safety of Machinery - Electro-sensitive Protective Equipment - Part 3: Passive Infra-red Protective Devices (PIPDs)
IEC 62046, Safety of Machinery - Application of Personnel Sensing Protection Equipment to Machinery (PSPE)
IEC 62061, Safety of Machinery - Functional Safety of Safety-Related Electrical, Electronic, and Programmable Electronic Control Systems
3.4 C 類產品安全性標準
C 類產品安全性標準包括適用於特定產品或系統,或一系列產品或系統的安全層面,且盡可能參考基本安全標穩與全組安全性標準,產品範例如機械工具、工業機器人、電梯、點焊機、無人運輸裝置、輸送帶等,常見的標準有:
ISO 10218-1, 《機器人與機器人裝置 - 工業機器人安全性需求 - 第 1 部:機器人》(Robots and robotic devices - Safety requirements for industrial robots - Part 1: Robots)。
ISO 3691, 《工業貨車 - 安全性標準與驗證》(Industrial trucks - Safety requirements and verification)
ISO 447:1984 (ed2.0), 《工具機 - 控制操作指導》(Machine tools - Direction of operation of controls)
安全性標準 (safety standards) 坊間不少資料直接引用日本用語稱之為安全規格或簡稱安規,甚至於我國主管國家標準的經濟部標檢局,在 2011 年 2 月 15 日發行的標準資料電子報第 37 期有關 ISO 12100:2010 的報導,也是將 standard 翻譯為規格,那麼不知道標檢局怎麼定義 specification 的中文名稱,規格或規範。網路上可以下載的機器安全技術指南 (safety technical guidelines),日本人或日本工業標準委員會 (Japan Industrial Standard Committee, JISC) 對國際標準體系的 Technical Specification 稱為技術仕樣書。
JIS-B-9702:2000 = ISO-14121:1999, Safety of Machinery - Principle of Risk Assessment (Translated and Published by Japanese Standards Association)