STANDARDS &
REGULATIONS

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Occupational Safety and Health Administration (OSHA)

Overview of the OSHA Standard

One or more methods of machine guarding shall be provided to protect the operator and other employees in the machine area from hazards such as those created by point of operation, ingoing nip points, rotating parts, flying chips and sparks. Moving machine parts have the potential for causing severe workplace injuries, such as crushed fingers or hands, amputations, burns and blindness, just to name a few. Safeguards are essential for protecting workers from these needless and preventable injuries. Machine guarding and related machinery violations continuously rank among the top 10 of OSHA citations issued. Mechanical power presses have also become an area of increasing concern.

1910.212 (a)(1): General Duty Clause

Any machine part, function, or process which may cause injury must be safeguarded. When the operation of a machine, or accidental contact with it, can injure the operator or others in the vicinity, the hazards must be either controlled or eliminated.

29CFR1910.147: The Control of Hazardous Energy (Lockout/Tagout)

This standard establishes the minimum performance requirements for the servicing and maintenance of machines and equipment in which the unexpected start-up of the machines and equipment, or release of stored energy, could harm employees.

29CFR1910.212: General Requirements of all Machinery and Machine Guarding

This standard requires that any machine part, function or process which may cause injury must be safeguarded. The guard shall be such that it does not offer an accident hazard in itself.

29CFR1910.213: Woodworking Machinery Requirements

This standard gives detailed requirements for machinery use for woodworking. This includes, but is not limited to, table saws, band saws, scroll saws, lathes, jointers, shapers, planers, molders, drill presses, belt sanders, and tenoning machines.

29CFR1910.215: Abrasive Wheel Machinery

This standard gives more detail requirements for machines which use an abrasive wheel against the material’s surface causing a change in the surface or shape.

29CFR1910.216: Mill & Calendar Requirements

This standard gives detailed requirements for machines which are capable of producing a bend across the width of a flat piece of metal by means of one or more rotating dies or rolls.

29CFR1910.217: Mechanical Power Press Requirements

This standard gives requirements for mechanically-powered machines that shear, punch, form, or assemble materials by means of cutting, shaping, or combination dies which attach to the sides.

29CFR1910.218: Forging Machine Requirements

Standard requirements for hot metal working machines which strike hot metal between two dies to form the metal into a desired shape.

29CFR1910.219: Mechanical Power Transmission Apparatus

Standard requirements for safeguarding power transmission including all mechanical parts, such as gears, cams, shafts, pulleys, belts, clutches, brakes and rods that transmit energy and motion from a source of power to equipment or a machine.

National Fire Protection Association (NFPA)

NFPA 70: National Electric Code

Adopted in all 50 states, the NEC is the benchmark for safe electrical design, installation, and inspection to protect people and property from electrical hazards.

NFPA 70E: Standards for Electrical Safety in the Workplace

Protects personnel by reducing exposure to major electrical hazards. NFPA 70E helps companies and employees avoid workplace injuries and fatalities due to shock, electrocution, arc flash, and arc blast.

NFPA 79: Electrical Standard for Industrial Machinery

Provides safeguards for industrial machinery to protect operators and equipment from electrical and fire hazards. Applies to electrical machines operating under or at 600 volts, and starts at the point of connection of the supply and electrical equipment of the machine.

American National Standards Institute (ANSI)

ANSI B11.1-B11.18

Machine Tool Safety Standards

ANSI B11.19

Machine Tools Safeguarding When Reinforced by the Other B11 Machine Tool Safety Standards – Performance Criteria for Design, Construction, Care and Operation

ANSI B11.TR1

Ergonomic Guidelines for the Design, Installation and Use of Machine Tools

ANSI B11.TR3

Risk Assessment and Reduction – A Guide to Estimate, Evaluate, and Reduce Risks Associated with Machine Tools

ANSI B11.TR4

Selection of PES/PLC

ANSI B11.TR6

Control Reliable Circuits

ANSI/RIA R15.06

Safety Requirements for Industrial Robots and Robot Systems

ANSI B15.1

Safeguarding of Mechanical Power Transmission Apparatus

ANSI B20.1

Safeguarding of Conveyors

ANSI/ASSE Z244.1 2003 (R2008)

Control of Hazardous Energy – Lockout/Tagout and Alternative Methods

International Standards Organization (ISO)

ISO 4413

Hydraulic Fluid Power – General Rules Related to Systems

ISO 4414

Pneumatic Fluid Power – General Rules Related to Systems

ISO 12100-1

Safety of Machinery – Basic Concepts, General Principles for Design – Part 1: Basic Terminology Methodology

ISO 12100-2

Safety of Machinery – Basic Concepts, General Principles for Design – Part 2: Technical Principles

ISO 13732-2

Ergonomics of the Thermal Environment – Touching of Cold Surfaces Part 3: Ergonomic Data and Guidance for Application

ISO 13489-1

Safety of Machinery – Safety Related Parts of Control Systems – Part 100 – Guidelines for the Use and Application of ISO 13489

ISO 13849-1

Safety of Machinery – Safety-Related Parts of Control Systems – Part 1: General Principles for Design

Provides safety requirements and guidance on the principles for the design and integration of safety-related parts of control systems (SRP/CS), including the design of software. For these parts of SRP/CS, it specifies characteristics that include the performance level required for carrying out safety functions. It applies to SRP/CS for high demand and continuous mode, regardless of the type of technology and energy used (electrical, hydraulic, pneumatic, mechanical, etc.), for all kinds of machinery.

ISO 13849-2

Safety of Machinery – Safety Related Parts of Control Systems – Part 2: Validation

Specifies the procedures and conditions to be followed for the validation by analysis and testing of the specified safety functions, the category achieved, and the performance level achieved by the safety-related parts of a control system (SRP/CS) designed in accordance with ISO 13849-1.

ISO 13850

Safety of Machinery – Emergency Stop – Principles of Design

ISO 13852

Safety of Machinery – Safety Devices to Prevent Danger Zones Being Reached by Upper Limbs

ISO 13853

Safety of Machinery – Safety Devices to Prevent Danger Zones Being Reached by Lower Limbs

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 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 14121-1

Safety of Machinery – Risk Assessment – Part 1 Principles

ISO 13732-3

Ergonomics of the Thermal Environment – Touching of Cold Surfaces Part 3: Ergonomic Data and Guidance for Application

International Electrotechnical Commission (IEC)

IEC 61496-1

Safety of Machinery – Electro-Sensitive Protective Equipment – Part 1: General Requirements and Test

IEC 61496-2

Safety of Machinery – Electro-Sensitive Protective Equipment – Part 2: Particular Requirements for Equipment Using Active Opto-Electronic Protective Devise (AOPDs)

IEC 61508-1

Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems – Part 1: General Requirements

IEC 62061

Safety of Machinery – Functional Safety of Safety-Related Electrical, Electronic and Programmable Electronic Control Systems

IEC 62508-3

Safety of Machinery – Functional Safety of Electrical, Electric and Programmable Electronic Safety-Related Systems – Part 3: Software Requirements

European Standards (EN)

EN 292-1

Safety of Machinery – Basic Concepts, General Principles for Design. Part 1: Basic Terminology and Methodology.

EN 292-2

Safety of Machinery – Basic Concepts, General Principles for Design. Part 2: Technical Principles and Specifications.

EN 294

Safety of Machinery – Safety Distance to Prevent Danger Zones Being Reached by the Upper Limbs

EN 349

Safety of Machinery – Minimum Distances to Avoid Crushing Parts of the Human Body

EN 418

Emergency Stop Equipment

EN 574

Safety of Machinery – Two hand Control Devices – Functional Aspects – Principles for Design

EN 775

Manipulating Industrial Robots – Safety (ISO 10218:1992, Modified)

EN 811

Safety of Machinery – Safety Distances to Prevent Danger Being Reached by the Lower Limbs

EN 953

Safety of Machinery – Guards – General Requirements for the Design and Construction of Fixed and Moveable Guards

EN 954-1

Safety of Machinery – Safety Related Parts of Control Systems – General Principles for Design

EN 999

Safety of Machinery – The Positioning of Protective Equipment in Respect of Approach Speeds of Parts of the Human Body

EN 1037

Safety of Machinery – Prevention of Unexpected Start-Up

EN 1088

Safety of Machinery – Interlocking Devices Associated with Guards:  Principles for Design and Selection

EN 1760-1

Safety of Machinery – Pressure Sensitive Safety Devices – Mats and Floors

EN 1760-2

Safety of Machinery – Pressure Sensitive Safety Devices – Edges and Bars

EN 1921

Industrial Automation Systems

EN 60204-1

Electrical Equipment of Machines

EN 60947-5-1

Control Circuit Devices and Switching Elements

EN 61496-1

Safety of Machinery – Electro-Sensitive Protective Equipment – Part 1: General Requirements and Test

EN 61496-2

Safety of Machinery – Electro-Sensitive Protective Equipment – Part 2: Particular Requirements for Equipment Using Active Opto-Electronic Protective Devices (AOPDs)

Current Good Manufacturing Practices (CGMPs)

FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

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