STANDARDS &
REGULATIONS

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Note: Standards are subject to change. MPSA will always reference updated standards when undertaking any safety projects.

Page revision date: 8/21

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.

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.

ANSI B11.

Machine Tools Safety Package

ANSI B11.0 / ANSI B11.1 / ANSI B11.19

Safeguarding Mechanical Power Presses Package

ANSI B11.0 / ANSI B11.19 / B11.TR3

Risk Assessment and Safeguarding of Machinery Package

ANSI B11.20 / ANSI B11.19 / ANSI B11.0

Integrated Manufacturing Safety Systems Package

ANSI/ASSE Z244.1 / ANSI B11.19

Hazardous Energy Safeguarding Package

ASME B20.1 / ANSI B11.19 / ANSI/ASSE A1264.1 / ANSI/ASSE Z244.1

Conveyors and Walking Surfaces Safety Package

NFPA 70E / ANSI B11.19 / ANSI/ASSE Z244.1

Electrical Workplace Safeguarding Package

ANSI B11.0 / ANSI B11.26 / ANSI B11.19

Functional Safety – Control Systems and Risk Assessment for Machinery Package

ANSI B11.0 / B11.TR6 / ANSI B11.19

Control Systems and Risk Assessment for Machine Tools Package

ANSI B11.1 / ANSI B11.3 / ANSI B11.19

Mechanical Power Presses and Brakes Safety Package

ANSI B11.19 / ANSI B11.20

Integrated Manufacturing Systems Set

ANSI B11.20 / ANSI B11.19 / NFPA 79 / ANSI/ASSE Z244.1

Integrated Manufacturing Systems Collection

ANSI/RIA R15.06 / ANSI B11.0 / ANSI B11.19

Industrial Robots and Machinery Safety Package

ASME B20.1 / ANSI B11.19

Conveyors Safety Set

ASME B20.1 / ANSI B11.19 / ANSI B11.0

Conveyors Safety Package

ISO 4413

Hydraulic Fluid Power – General Rules Related to Systems

ISO 4414

Pneumatic Fluid Power – General Rules Related to Systems

ISO 12100

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

ISO 13732-2

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

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 12100:2010

Safety of Machinery – General Principles for Design – Risk Assessment and Risk Reduction

ISO 13732-3

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

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)

Please Note: Most EN standards have now been incorporated into the ISO/IEC standards.

EN 292-1

BS EN ISO 12100.1:2003+A1:2009

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

EN 292-2

BS EN ISO 12100.2:2003+A1:2009

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

EN 294

BS EN ISO 13857:2008

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

EN 349

BS EN ISO 13854:2019

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

EN 418

BS EN ISO 13850:2006

Emergency Stop Equipment

EN 574

BS EN ISO13851:2019

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 999

BS EN ISO 13855:2010

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

EN 1037

BS EN IO 14118:2018

Safety of Machinery – Prevention of Unexpected Start-Up

EN 1088

BS EN ISO 14119:2013

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

EN 1760-1

BS EN ISO 13856-1:2013

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

BS EN IEC 60204-1:2018

Electrical Equipment of Machines

EN 60947-5-1

BS EN IEC 60947-5-1:2017

Control Circuit Devices and Switching Elements

EN 61496-1

BS EN IEC 61496-1:-2020

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

EN 61496-2

BS EN IEC 61496-2:2020

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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