California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 4 - Division of Industrial Safety › Subchapter 7 - General Industry Safety Orders › Group 8 - Points of Operation and Other Hazardous Parts of Machinery › Article 55 - Power Operated Presses › Appendix A - Requirements for Certification/Validation of Safety Systems for Presence Sensing Device Initiation of Mechanical Power Presses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Purpose
The purpose of the certification/validation of safety
						  systems for presence sensing device initiation (PSDI) of mechanical power
						  presses is to ensure that the safety systems are designed, installed, and
						  maintained in accordance with all applicable requirements of sections
						  4192 through
						  4211 and this Appendix A.
General
The certification/validation process shall utilize an
						  independent third-party validation organization recognized by the U.S. Labor
						  Department, Occupational Safety and Health Administration (OSHA) in accordance
						  with the requirements specified in Appendix C of paragraph (h),
						  29 CFR
						  1910.217, revised March 14, 1988 which is
						  hereby incorporated by reference.
While the employer is responsible for assuring that
						  certification/validation requirements in section
						  4208.1(k) are
						  fulfilled, the design certification of PSDI safety systems may be initiated by
						  manufacturers, employers, and/or their representatives. The term
						  "manufacturers" refers to the manufacturer of any of the components of the
						  safety system. An employer who assembles a PSDI safety system would be a
						  manufacturer as well as employer for purposes of section
						  4208.1 and this Appendix A.
The certification/validation process includes two
						  stages. For design certification, in the first stage, the manufacturer (which
						  can be an employer) certifies that the PSDI safety meets the applicable
						  requirements of sections
						  4192 through
						  4211 and this Appendix A, based on
						  appropriate design criteria and tests. In the second stage, the
						  Division-recognized third-party validation organization validates that the PSDI
						  safety system meets the applicable requirements of sections
						  4192 through
						  4211 and this Appendix A and the
						  manufacturer's certification by reviewing the manufacturer's design and test
						  data and performing any additional reviews required by sections
						  4192 through
						  4211.
For installation certification/validation and annual
						  recertification/revalidation, in the first stage, the employer certifies or
						  recertifies that the employer is installing or utilizing a PSDI safety system
						  validated as meeting the applicable design requirements of sections
						  4192 through
						  4211 and this Appendix A by a
						  Division-recognized third-party validation organization and that the
						  installation, operation and maintenance meet the applicable requirements of
						  sections 4192 through
						  4211 and this Appendix A. In the
						  second stage, the Division-recognized third-party validation organization
						  validates or revalidates that the PSDI safety system installation meets the
						  applicable requirements of sections
						  4192 through
						  4211 and this Appendix A and the
						  employer's certification, by reviewing that the PSDI safety system has been
						  certified; the employer's certification, designs and tests, if any; the
						  installation, operation, maintenance and training; and by performing any
						  additional tests and reviews which the validation organization believes is
						  necessary.
Summary
The certification/validation of safety systems for PSDI
						  shall consider the press, controls, safeguards, operator, and environment as an
						  integrated system which shall comply with all of the applicable requirements in
						  sections 4192 through
						  4211 and this Appendix A. The
						  certification/validation process shall verify that the safety system complies
						  with the safety requirements as follows:
A. Design Certification/Validation.
1. The major parts, components and subsystems used
						  shall be defined by part number or serial number, as appropriate, and by
						  manufacturer to establish the configuration of the system.
2. The identified parts, components and subsystems
						  shall be certified by the manufacturer to be able to withstand the functional
						  and operational environments of the PSDI safety system.
3. The total system design shall be certified by the
						  manufacturer as complying with the applicable requirements in sections
						  4192 through
						  4211 and this Appendix A.
4. The third-party validation organization shall
						  validate the manufacturer's certification under paragraphs 2 and 3.
B. Installation Certification/Validation.
1. The employer shall certify that the PSDI safety
						  system has been design certified and validated, that the installation meets the
						  operational and environmental requirements specified by the manufacturer, that
						  the installation drawings are accurate, and that the installation meets the
						  applicable requirements of sections
						  4192 through
						  4211 and this Appendix A. (The
						  operational and installation requirements of the PSDI safety system may vary
						  for different applications.)
2. The third-party validation organization shall
						  validate the employer's certifications that the PSDI safety system is design
						  certified and validated, that the installation meets the installation and
						  environmental requirements specified by the manufacturer, and that the
						  installation meets the applicable requirements of sections
						  4192 through
						  4211 and this Appendix A.
C. Recertification/Revalidation.
1. The PSDI safety system shall remain under
						  certification/validation for the shorter of one year; or until the system
						  hardware is changed, modified or refurbished; or operating conditions are
						  changed (including environmental, application or facility changes); or a
						  failure of a critical component has occurred.
2. Annually or after a change specified in paragraph
						  1., the employer shall inspect and recertify the installation as meeting the
						  requirements set forth under paragraph B., Installation
						  Certification/Validation.
3. The third-party validation organization, annually or
						  after a change specified in paragraph 1., shall validate the employer's
						  certification that the requirements of paragraph B., Installation
						  Certification/Validation, have been met.
NOTE: Such changes in operational conditions as die
						  changes or press relocations not involving disassembly or revision to the
						  safety system would not require recertification/revalidation.)
Certification/Validation
						  Requirements
A. General Design Certification/Validation
						  Requirements
1. Certification/Validation Program Requirements. The
						  manufacturer shall certify and the Division-recognized third-party validation
						  organization shall validate that:
a. The design of components, subsystems, software and
						  assemblies meets applicable performance requirements and are ready for the
						  intended use; and
b. The performance of combined subsystems meets
						  applicable operational requirements.
2. Certification/Validation Program Level of Risk
						  Evaluation Requirements. The manufacturer shall evaluate and certify, and the
						  Division-recognized third-party validation organization shall validate the
						  design and operation of the safety system by determining conformance with the
						  following:
a. The safety system shall have the ability to sustain
						  a single failure or a single operating error and not cause injury to personnel
						  from point of operation hazards. Acceptable design features shall demonstrate,
						  in the following order or precedence, that:
(1) No single failure points may cause injury;
						  or
(2) Redundancy, comparison, and/or diagnostic checking
						  exist for the critical items that may cause injury, and the electrical,
						  electronic, electromechanical, and mechanical parts and components are selected
						  so that they can withstand operational and external environments. The safety
						  factor and/or derated percentage shall be specifically noted and complied
						  with.
b. The manufacturer shall design, evaluate, test and
						  certify, and the third-party validation organization shall evaluate and
						  validate, that the PSDI safety system meets appropriate requirements in the
						  following areas:
(1) Environmental Limits
(a) Temperature
(b) Relative humidity
(c) Vibration
(d) Fluid compatibility with other materials
(2) Design Limits
(a) Power Requirements
(b) Power transient tolerances
(c) Compatibility of materials used
(d) Material stress tolerances and limits
(e) Stability to long term power fluctuations
(f) Sensitivity to signal acquisition
(g) Repeatability of measured parameter without
						  inadvertent initiation of a press stroke
(h) Operational life of components in cycles, hours, or
						  both
(i) Electromagnetic tolerance to:
1. Specific operational wave lengths; and
2. Externally generated wave lengths
3. New Design Certification/Validation. Design
						  certification/validation for a new safety system, i.e., a new design or new
						  integration of specifically identified components and subsystems, would entail
						  a single certification/validation which would be applicable to all identical
						  safety systems. It would not be necessary to repeat the tests on individual
						  safety systems of the same manufacture or design. Nor would it be necessary to
						  repeat these tests in the case of modifications where determined by the
						  manufacturer and validated by the third-party validation organization to be
						  equivalent by similarity analysis. Minor modifications not affecting the safety
						  of the system may be made by the manufacturer without revalidation.
Substantial modifications would require testing as a
						  new safety system, as deemed necessary by the validation organization.
B. Additional Detailed Design Certification/Validation
						  Requirements
1. General. The manufacturer or the manufacturer's
						  representative shall certify to and submit to a Division-recognized third-party
						  validation organization the documentation necessary to demonstrate that the
						  PSDI safety system design is in full compliance with the requirements of
						  sections 4192 through
						  4211 and this Appendix A, as
						  applicable, by means of analysis, tests, or combination of both, establishing
						  that the following additional certification/validation requirements are
						  fulfilled.
2. Reaction Times. For the purpose of demonstrating
						  compliance with the reaction time required by section
						  4208.1, the tests shall use the
						  following definitions and requirements:
a. "Reaction time" means the time, in seconds, it takes
						  the signal, required to activate/deactivate the system, to travel through the
						  system, measured from the time of signal initiation to the time the function
						  being measured is completed.
b. "Full Stop" or "No movement of the slide or ram"
						  means when the crankshaft rotation has slowed to two or less revolutions per
						  minute, just before stopping completely.
c. "Function completion" means for electrical,
						  electromechanical and electronic devices, when the circuit produces a change of
						  state in the output element of the device.
d. When the change of state is motion, the measurement
						  shall be made at the completion of the motion.
e. The generation of the test signal introduced into
						  the system for measuring reaction time shall be such that the initiation time
						  can be established with an error of less than 0.5 percent of the reaction time
						  measured.
f. The instrument used to measure reaction time shall
						  be calibrated to be accurate to within 0.001 second.
3. Compliance with section
						  4208.1(b)(2). For
						  compliance with these requirements, the average value of the stopping time (Ts)
						  shall be the arithmetic mean of at least 25 stops for each stop angle
						  initiation measured with the brake and/or clutch unused, 50 percent worn, and
						  90 percent worn. The recommendations of the brake system manufacturer shall be
						  used to simulate or estimate the brake wear. The manufacturer's recommended
						  minimum lining depth shall be identified and documented, and an evaluation made
						  that the minimum depth will not be exceeded before the next (annual)
						  recertification/revalidation. A correlation of the brake and/or clutch
						  degradation based on the above tests and/or estimates shall be made and
						  documented. The results shall document the conditions under which the brake
						  and/or clutch will and will not comply with the requirement. Based upon this
						  determination, a scale shall be developed to indicate the allowable 10 percent
						  of the stopping time at the top of the stroke for slide or ram overtravel due
						  to brake wear. The scale shall be marked to indicate that brake adjustment
						  and/or replacement is required. The explanation and use of the scale shall be
						  documented.
The test specification and procedure shall be submitted
						  to the validation organization for review and validation prior to the test. The
						  validation organization representative shall witness at least one set of
						  tests.
4. Compliance with sections
						  4208.1(e)(3) and
						  (i)(6). Each reaction time required to
						  calculate the Safety Distance, including the brake monitor setting, shall be
						  documented in separate reaction time tests. These tests shall specify the
						  acceptable tolerance band sufficient to assure that tolerance build-up will not
						  render the safety distance unsafe.
a. Integrated test of the press fully equipped to
						  operate in the PSDI mode shall be conducted to establish the total system
						  reaction time.
b. Brakes which are the adjustable type shall be
						  adjusted properly before the test.
5. Compliance with section
						  4208.1(b)(3).
a. Prior to conducting the brake system test required
						  by section 4208.1(b)(2), a
						  visual check shall be made of the springs. The visual check shall include a
						  determination that the spring housing or rod does not show damage sufficient to
						  degrade the structural integrity of the unit and the spring does not show any
						  tendency to interleave.
b. Any detected broken or unserviceable springs shall
						  be replaced before the test is conducted. The test shall be considered
						  successful if the stopping time remains within that which is determined by
						  section 4208.1(i)(6), for
						  the safety distance setting. If the increase in press stopping time exceeds the
						  brake monitor setting limit defined in section
						  4208.1(e)(3), the
						  test shall be considered unsuccessful and the cause of the excessive stopping
						  time shall be investigated. It shall be ascertained that the springs have not
						  been broken and that they are functioning properly.
6. Compliance with section
						  4208.1(g).
a. Tests which are conducted by the manufacturers of
						  electrical components to establish stress, life, temperature and loading limits
						  must be tests which are in compliance with the provisions of the National
						  Electrical Code.
b. Electrical and/or electronic cards or boards
						  assembled with discreet components shall be considered a subsystem and shall
						  require separate testing that the subsystems do not degrade in any of the
						  following conditions:
(1) Ambient temperature variation from 20° C to
						  -50° C.
(2) Ambient relative humidity of 99 percent.
(3) Vibration of 45G for one millisecond per stroke
						  when the item is to be mounted on the press frame.
(4) Electromagnetic interference at the same
						  wavelengths used for the radiation sensing field, at the power line frequency
						  fundamental and harmonics, and also from autogenous radiation due to system
						  switching.
(5) Electrical power supply variations of -15
						  percent.
c. The manufacturer shall specify the test requirements
						  and procedures from existing consensus tests in compliance with the provisions
						  of the National Electrical Code.
d. Tests designed by the manufacturer shall be made
						  available upon request to the validation organization. The validation
						  organization representative shall witness at least one set of each of these
						  tests.
7. Compliance with section
						  4208.1(i)(5).
a. The manufacturer shall design a test to demonstrate
						  that the prescribed minimum object sensitivity of the presence sensing device
						  is met.
b. The test specifications and procedures shall be made
						  available upon request to the validation organization.
8. Compliance with section
						  4208.1(i)(11).
a. The manufacturer shall design a test(s) to establish
						  the hand tool extension diameters allowed for variations in minimum object
						  sensitivity response.
b. The test(s) shall document the range of object
						  diameter sizes which will produce both single and double break
						  conditions.
c. The test(s) specifications and procedures shall be
						  made available upon request to the validation organization.
9. Integrated Tests Certification/Validation.
a. The manufacturer shall design a set of integrated
						  tests to demonstrate compliance with the following requirements:
Sections
						  4208.1 f(2), (3), (4), (5), (6),
						  (7), (8), (9), (11), (12), (13), (14) and (16).
b. The integrated test specifications and procedures
						  shall be made available to the validation organization.
10. Analysis.
a. The manufacturer shall submit to the validation
						  organization the technical analysis such as Hazard Analysis, Failure Mode and
						  Effect Analysis, Stress Analysis, Component and Material Selection Analysis,
						  Fluid Compatibility, and/or other analyses which may be necessary to
						  demonstrate compliance with the following requirements:
Sections
						  4201.8 (b)(1),
						  (3),; (c)(1)(A), (c)(1)(C), (c)(2); (e)(1),
						  (2), (3); (f)(1), (3), (4), (6), (7), (8), (9), (10), (11), (12), (13), (14),
						  (15), (16); (g); (h)(1), (2); (i)(5), (6), (9), (10), (11); (j)(1) and
						  (2).
11. Types of tests Acceptable for
						  Certification/Validation.
a. Test results obtained from development testing may
						  be used to certify/validate the design.
b. The test results shall provide the engineering data
						  necessary to establish confidence that the hardware and software will meet
						  specifications; the manufacturing process has adequate quality control; and the
						  data acquired was used to establish processes, procedures, and test levels
						  supporting subsequent hardware design, production, installation and
						  maintenance.
12. Validation for Design
						  Certification/Validation.
If, after review of all documentation, tests, analyses,
						  manufacturer's certifications, and any additional tests which the third-party
						  validation organization believes are necessary , the third-party validation
						  organization determines that the PSDI safety system is in full compliance with
						  the applicable requirements of sections
						  4192 through
						  4211 and this Appendix A, it shall
						  validate the manufacturer's certification that it so meets the stated
						  requirements.
C. Installation Certification/Validation
						  Requirements
1. The employer shall evaluate and test the PSDI system
						  installation, shall submit to the Division-recognized third-party validation
						  organization the necessary supporting documentation, and shall certify that the
						  applicable requirements of sections
						  4192 through
						  4211 and this Appendix A have been
						  met and that the installation is proper.
2. The Division-recognized third-party validation
						  organization shall conduct tests, and/or review and evaluate the employer's
						  installation tests, documentation and representations. If it so determines, it
						  shall validate the employer's certification that the PSDI safety system is in
						  full conformance with all applicable requirements of sections
						  4192 through
						  4211 and this Appendix A.
D. Recertification/Revalidation Requirements
1. A PSDI safety system which has received installation
						  certification/validation shall undergo recertification/revalidation the earlier
						  of:
a. Each time the systems hardware is significantly
						  changed, modified, or refurbished;
b. Each time the operational conditions are
						  significantly changed (including environmental, application or facility
						  changes, but excluding such changes as die changes or press relocations not
						  involving revision to the safety system);
c. When a failure of a significant component has
						  occurred or a change has been made which may affect safety; or
d. When one year has elapsed since the installation
						  certification/validation or the last recertification/revalidation.
2. Conduct of recertification/revalidation. The
						  employer shall evaluate and test the PSDI safety system installation, shall
						  submit to the Division-recognized third-party validation organization the
						  necessary supporting documentation, and shall recertify that the applicable
						  requirements of sections
						  4192 through
						  4211 and this Appendix are being
						  met. The documentation shall include, but not be limited to, the following
						  items:
a. Demonstration of a thorough inspection of the entire
						  press and PSDI safety system to ascertain that the installation, components and
						  safeguarding have not been changed, modified or tampered with since the
						  installation certification/validation or last recertification/revalidation was
						  made.
b. Demonstrations that such adjustments as may be
						  needed (such as to the brake monitor setting) have been accomplished with
						  proper changes made in the records and on such notices as are located on the
						  press and safety system.
c. Demonstration that review has been made of the
						  reports covering the design certification/validation, the installation
						  certification/validation, and all recertification/revalidations in order to
						  detect any degradation to an unsafe condition, and that necessary changes have
						  been made to restore the safety system to previous certification/validation
						  levels.
3. The Division-recognized third-party validation
						  organization shall conduct tests, and/or review and evaluate the employer's
						  installation, tests, documentation and representations. If it so determines, it
						  shall revalidate the employer's recertification that the PSDI system is in full
						  conformance with all requirements of sections
						  4192 through
						  4211 and this Appendix
						  A.
1. New
						  Appendix A filed 4-20-90; operative 5-20-90 (Register 90, No.
						  20).