Standards and Regulations/Directives

B11.19 and PMMI Members

By Bruce Main, president, design safe engineering, inc.

While packaging and processing companies go about their daily work, behind the scenes, there are groups of people from all different facets of business, meeting to work on machinery safety standards.  These standards exist to guide companies on how best to build their machines to keep workers and customers safe from harm. 
 
PMMI is active in standards development for packaging and processing machinery and is the secretary for ANSI/PMMI B155.1 Safety Requirements for Packaging and Processing Machinery.  The requirements for safeguarding machinery in B155.1 are contained in ANSI B11.19.  Rather than write duplicate requirements, B155.1 incorporates these requirements by reference.   
 
A new and improved version of ANSI B11.19 has just been released.  ANSI B11.19 – Performance Requirements for Risk Reduction Measures, Safeguarding and other Means of Reducing Risk.   This newly revised standard contains substantial changes from the prior 2010 edition.  In addition to changing the title of the document, the committee made a major organizational revision of the standard using the hazard control hierarchy as a guide for the general structure.  The hazard control hierarchy is discussed in greater detail in ANSI/PMMI B155.1 and acts as a companion document to B11.19.  While B155.1 addresses the risk assessment process and choosing appropriate risk reduction measures, B11.19 describes how to apply the risk reduction measures selected.   

General  
The primary objective of this standard is to establish the requirements for the design, construction, installation, operation and maintenance of the risk reduction measures used to eliminate or control hazards to individuals associated with machines. This standard relies on other standards to determine which risk reduction measure(s) is required or allowed to control identified hazards/hazardous situations and is intended to be used in conjunction with the ANSI B155.1 standard on general safety requirements and risk assessments of packaging and processing machinery. To accomplish this objective, this standard has established responsibilities for the supplier (e.g., manufacturer, rebuilder, installer, integrator and modifier), the user and individuals in the working environment. The overall goal is to achieve acceptable risk in the work practices and work environment.  

Application  
The words "safe" and "safety" are not absolutes. Safety begins with good design. While the goal of this standard is to eliminate injuries, this standard recognizes that risk factors cannot practically be reduced to zero in any human activity. This standard is not intended to replace good judgment and personal responsibility. Operator skill, attitude, training, job monotony, fatigue and experience are factors that affect safety and that must be considered by the user.  

Harmonization  
The requirements of this standard have been harmonized with similar requirements in several international (ISO and IEC) and European (EN) standards. Harmonization means that the requirements have been aligned in essence to achieve a similar level of risk reduction. Harmonization does not mean duplication of exact requirements.  
 
ANSI B11.19 implements a standardization philosophy that differs significantly from that often found in some ISO, IEC and EN standards. These standards tend towards individual documents for each type of risk reduction measure (e.g., light curtains, emergency stop controls, prevention of unexpected start-up, etc.). ANSI B11.19 has historically combined the various requirements into this single standard, thereby allowing readers to understand and compare the requirements for different approaches to reducing risk.  

Considerable effort has been made to avoid conflicting requirements. However, that task is quite challenging because the various standards do not ‘align’ directly in scope, requirements, approaches and revision dates. Several annexes are provided in ANSI B11.19 to assist readers in identifying and understanding the correlation of the various national and international standards. ISO standards tend to be very directive or prescriptive in nature, thus possibly limiting solutions for particular applications. ANSI B11.19 tends to include more performance-based requirements and allows suppliers and users to develop effective solutions using risk assessment as justification.  
 
Differences between ANSI B11.19 and ISO standards result from different analytical methods or approaches. However, the differences between the requirements are generally considered inconsequential to the achievement of acceptable risk or to compliance with the EU Machinery Directive 2006/42/EC, OSHA (specifically, 29 CFR 1910.212(a)(1)), or other legal requirements. As a result, using risk assessment as described by ANSI/PMMI B155.1, and complying with the requirements of ANSI B11.19 will enable a machine supplier to meet the essential safety and health requirements contained in Annex I of the EU Machinery Directive 2006/42/EC when used as alternate technical specifications to EU harmonized standards.  
 

This 2019 revision of ANSI B11.19 contains substantial and significant changes from the 2010 edition, including:

  • a change in title as well as a major organizational revision of the standard using the hazard control hierarchy as a general structure of this standard;
  • removal of the concept of “complementary equipment and measures;”
  • improved and harmonized definitions of terms used in the standard;
  • clarification of the responsibilities of the supplier, user, integrator/modifier/rebuilder, and personnel;
  • enhanced and harmonized requirements throughout the standard;
  • addition of requirements for partial guards, nip guards, and trapped (captive) key;
  • a segmentation of perimeter guards (barriers), perimeter risk reduction measures and whole body access;
  • addition of requirements for control functions, including safe conditions (safe motion, safe speed, etc.), safety-related reset, safety-related sensing field switching, whole body access and span of control;
  • additional guidance in informative annexes including a significant addition to safety distance and reaching distance for both protective structures and devices;
  • additional content for risk reduction measures not previously included in prior versions of ANSI B11.19.  

This revision of ANSI B11.19 also updates the terminology to clarify technical meaning with the intent to achieve greater precision in the terms used. 
 
Standards often include responsibilities for different parties involved.  B11.19 is no different.  Clarification has been given regarding the responsibilities of the supplier, user, integrator/modifier/rebuilder and personnel.  It is important to note that you will not find user responsibilities in ISO standards.  It is important for companies selling and using machines in different countries to note the different responsibilities.  
 
This is large 254-page document. This can easily be daunting to the user. The electronic version of the standard contains hot links throughout the document for easy maneuvering when other clauses are 
referenced. If you have great familiarity with the 2010 version of the standard will find a table in Annex P cross referencing the prior subclause topic location and their new location in the 2019 revision.   
 
The 2019 version of B11.19 includes additional guidance in informative annexes including a significant addition to Safety Distance and Reaching Distance for both protective structures and devices. It also contains additional content for risk reduction measures not previously included in prior versions of the standard.  
 
The selection of what safeguard should be used is based on risk as determined in a risk assessment per ANSI/PMMI B155.1. You should use B11.19 to address how to apply different safeguarding once a method has been selected. As a result, B11.19 applies very broadly to packaging and processing machinery, equipment and facilities where safeguarding is used.   
 
Packaging and processing machinery manufacturers should obtain and start to use the new ANSI B11.19 standard.  The standard can be purchased at https://webstore.ansi.org/Standards/AMT/ANSIB11192019 

 

ANSI B11.19 (2019) Table of Contents 

Forward

  1. Scope
  2. References
  3. Definitions
  4. Responsibility
    4.1 Supplier responsibilities
    4.2 User responsibilities  
    4.3 Integrator/modifier/rebuilder responsibilities  
    4.4 Personnel responsibilities  
  5. Risk assessment process
  6. Risk reduction measures
  7. Inherently safe by design
  8. Engineering controls – guards
    8.1 General requirements for guards  
    8.2 Fixed guards  
    8.3 Moveable guards  
    8.4 Interlocked guards
    8.5 Adjustable guards  
    8.6 Self-adjusting guards  
    8.7 Partial guards  
    8.8 Perimeter guards  
    8.9 Nip guards  
    8.10 Shields
  9. Engineering controls – control functions  
    9.1 General requirements for control functions  
    9.2 Performance of safety functions  
    9.3 Monitoring functions  
    9.4 Stop functions  
    9.5 Safety-related reset  
    9.6 Safety distance  
    9.7 Suspension of safety functions 
    9.8 Variable sensing functions  
    9.9 Presence-sensing device initiation (PSDI)  
    9.10 Perimeter risk reduction measures  
    9.11 Whole body access  
    9.12 Span of control
  10. Engineering controls – devices  
    10.1 General requirements of devices  
    10.2 Interlock devices  
    10.3 Trapped (captive) key systems  
    10.4 Interlock blocking devices  
    10.5 Moveable barrier devices  
    10.6 Pull back (pull out) and hold out (restraint) devices  
    10.7 Presence-sensing devices  
    10.8 Two-hand actuating controls  
    10.9 Single actuating controls  
    10.10 Hold-to-run control devices  
    10.11 Enabling devices  
    10.12 Emergency stop (E-stop) devices  
    10.13 Slide locks
  11. Administrative controls  
    11.1 General requirements for administrative controls  
    11.2 Awareness means  
    11.3 Information for use (human and organizational)  
    11.4 Administrative safeguarding methods  
    11.5 Supervision  
    11.6 Control of hazardous energy  
    11.7 Tools  
    11.8 Personal protective equipment (PPE)

Annex A    Guidance to Understand the ANSI B11 Series of Standards & Technical Reports
Annex B     Hazard List for Risk Reduction Measures
Annex C     Performance of the Safety Function (s)
Annex D     Comparison of Physical Barriers