New ISO 14155, 2011 2nd Edition, just released – Clinical investigation of medical devices for human subjects — Good clinical practice

Document Center now has the new ISO 14155:2011 Edition available for purchase.  The standard, titled Clinical investigation of medical devices for human subjects — Good clinical practice, withdraws and replaces both the ISO-14155-1 and the ISO-14155-2.

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

This new edition, as well as all the ISO standards, is available from Document Center Inc. at our website www.document-center.com.  You can also contact us by phone at 650-591-7600, fax at 650-591-7617 or by email at info@document-center.com.  We’re always happy to help you with any standards needs you may have.

New BS EN 55024 2010 Edition released

BS EN 55024 has just been released as the new 2010 edition.  The popular standard is titled “Information technology equipment. Immunity characteristics. Limits and methods of measurement.”  The date on the new edition is January 2011 and the document is available now from Document Center Inc.

The new BS EN 55024:2010  is the official English language edition of the EN 55024 and is identical to the CISPR 24, 2010 Edition.

It establishes uniform requirements for the electromagnetic immunity of information technology equipment. BS EN 55024 specifies applicable tests, test levels, product operating conditions and assessment criteria.  Test methods are then found in the referenced Basic EMC Immunity standards.

BS EN 55024 sets out the requirements to provide an adequate level of intrinsic immunity.  The goal is for the equipment to operate as intended in its environment.  The standard specifies the immunity test requirements for equipment defined in the scope in relation to continuous and transient, conducted and radiated disturbances, including electrostatic discharges (ESD).

Some tests are specified in defined frequency bands or at selected frequencies because of testing and performance assessment considerations.  Equipment which fulfils the requirements at these frequencies is deemed to fulfil the requirements in the entire frequency range from 0 Hz to 400 GHz for electromagnetic phenomena.

The test requirements are specified for each port considered.

This standard, and many more, are available from Document Cen5ter Inc. at www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Feel free to contact us with additional questions.

RTCA DO 160 New Revision G on Environmental Conditions and Test Procedures for Airborne Equipment

The New Revision G for the widely used RTCA DO-160 on Environmental Conditions and Test Procedures for Airborne Equipment has just been released.  The document is available for purchase from Document Center Inc.

DO-160G provides standard procedures and environmental test criteria for testing airborne equipment for a wide range of aircraft, from light, general aviation planes and helicopters to “jumbo jets” and SST’s.

The standard covers tests for vibration, power input, radio frequency susceptibility, lightning and electrostatic discharge.   It has 26 sections and three appendices.  The new edition replaces RTCA-DO-160F and all other previous editions.  However, the obsolete revisions are available from Document Center Inc. if required.

As a measure of the wide acceptance of the document, it is coordinated with EUROCAE, with EUROCAE/ED-14G being identical to the  RTCA/DO-160G. And it is also adopted as the international standard ISO-7137.

You can get this document by going to the Document Center website at www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll be happy to provide you with copies of this and many other publicly distributed standards or answer any standards questions you may have.

IPC SM 840 New Revision E on Permanent Solder Mask just released

IPC-SM-840, Revision E, on Qualification and Performance of Permanent Solder Mask has just been released and is available from Document Center Inc.

The new 19-page standard establishes the requirements for the evaluation of liquid and dry film solder mask material and for the determination of the acceptability of use on a standard printed board system.  It provides two classes of requirements, T and H, to reflect functional performance requirements and testing severity based on industry/end use requirements. Coverage is given to adhesion, material qualification, resistances to solvents, and electrical requirements.

The new Revision E incorporates requirements for flexible cover materials used as a flexible dielectric protective layer over etched conductors and other conductive features.

Copies of this popular IPC document and all IPC publications are available from Document Center Inc. at our website www.document-center.com.  You can also reach us by phone at 650-591-7600, fax at 650-591-7617, and via email at info@document-center.com.

We’ll be happy to assist you with any Standards needs you may have.

New MIL-STD-464 Revision C: Electromagnetic Environmental Effects Requirements for Systems

MIL-STD-464C, the Department of Defense’s primary Electromagnetic compatibility (EMC) standard for systems, has just been released.  It is one of Document Center’s best selling military documents.

It is the latest in a long line of standards that goes back to at least MIL‑I‑6051, “Interference Limits and Methods of Measurement; Aircraft Radio and Electronic Installations,” released in 1950. The MIL‑STD‑464 replaced MIL-I-6051D and several other documents in 1997.

MIL‑STD‑464 is the DoD top‑level EMC (aka E3, electromagnetic environmental effects) requirement set for procurement of complete or modified systems.  This might be airborne, sea, space, and ground systems (like a tank or a submarine), including associated ordnance.

This standard contains two sections, the main body and an appendix. The main body of the standard specifies a baseline set of requirements. The appendix portion provides rationale, guidance, and lessons learned for each requirement to enable the procuring activity to tailor the baseline requirements for a particular application. The appendix also permits Government and Industry personnel to understand the purpose of the requirements and potential verification methodology for a design. The appendix is not a mandatory part of this document.

The document states that changes are too numerous to identify due to the extent of the modifications.  However, apart from a few changes to section 2, the revisions seem to cluster in section 3.

This standard, previous editions, and all other publicly distributed DoD standards are available from Document Center Inc. via our website, www.document-center.com, email (info@document-center.com), phone (650-591-7600), and fax (650-591-7617).

Feel free to contact our expert sales staff with any additional questions you might have.

MIL-STD-1285 D, Marking of Electrical and Electronic Parts, has a New Change Notice 1 dated 11/10/2010

MIL-STD-1285, Revision D, has just been revised by Change Notice 1.  The standard, titled Marking of Electrical and Electronic Parts, has been required for use by military contractors since the 1960’s.

Here’s a summary of the changes that Change 1 makes to the MIL-STD-1285D:
1.  Foreword change DSCC name to DLA Land and Maritime
2.  Paragraph 2.2.1 changed the URL for the ASSIST quicksearch web site.
3.  Paragraph 2.3, add a Uniform Resource Locator (URL) for all documents sited; delete cancel document
“ANSI Y10.5” and add “IEEE 280”.
4.  Paragraph 2.4, changed to include the words “Unless otherwise noted herein or in the contract”.
5.  Paragraph 4.3, replaced cancel document “ANSI Y10.5” with superseded document “IEEE 280”.
6.  Paragraph 6.7 changed “Changes from previous issue” paragraph.
7.  Appendix K, paragraph K.2.2.1, changed the URL for the ASSIST quicksearch web site.
8.  Appendix K, Section K.2.3, changed to include the words “Unless otherwise noted herein or in the contract”.
9.  Appendix L, paragraph L.2.2.1, changed the URL for the ASSIST quicksearch web site.
10.  Appendix L, Section L.2.3 changed to include the words “Unless otherwise noted herein or in the contract”.
11.  Appendix N, Title change.
12.  Appendix N, paragraph N.2.2.1, changed the URL for the ASSIST quicksearch web site.
13.  Appendix N, paragraph N.2.3, add Non-Government publication paragraph.
14.  Appendix N, paragraph N.2.4, changed to include the words “Unless otherwise noted herein or in the contract”.
15.  Appendix N, paragraph N.3.1.1, add “card holders” to existing paragraph.
16.  Appendix N, paragraph N.3.1.2, rename paragraph title.
17.  Appendix N, paragraph N.3.1.2.1, rewritten paragraph.
18.  Appendix N, paragraph N.3.1.2.2, editorial changes.
19.  Appendix N, add paragraphs N.3.1.3, N.3.1.4, and N.3.1.4.1.
20.  Concluding material, changes “Air Force-11” to “Air Force-85” and the ASSIST quicksearch web site.

The new consolidated edition is available at our Document Center Inc. website (www.document-center.com) or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Please contact us with any and all questions on government and industry standards.

The perils of using free sites for Mil Specs and Standards

There have been a number of sites cropping up on the Internet that offer U.S. military documents for free.  As with most free things, it’s buyer beware!

We speculate that these sites are being generated as a easy method for generating advertising revenue on the various Mil Spec and Standard numbers.  However, for the user of these sites, there are 2 major drawbacks to relying on them for your documentation.

1.  The sites are not maintained, so that the document you download may not be the correct and latest edition of the document.

2.  The sites do not offer monitoring services, so that when the document changes you are not going to be notified.

If you need to comply with military specifications and standards, you need Document Center Inc. to be your supplier of choice.  We have been selling these documents since 1982 and have a long history of providing customers with timely delivery at fair prices for these items.

We monitor over 400,000 standards for our customers, notifying them of changes either on a nightly or bi-monthly basis.  The notification service is either free with the purchase of the standard or can be purchased separately.

Just because a site claims to have “every spec” or “mil-standard” doesn’t mean it’s so.

Contact us at www.document-center.com, by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our standards experts can help you identify the correct document for your needs, and will help keep you up-to-date as well!

MIL-E-17555H has been cancelled without replacement

MIL-E-17555H with Amendment 2, Electronic and Electrical Equipment, Accessories, and Provisioned Items (Repair Parts): Packaging of, has been cancelled.  The document has no replacement.

This will create a challenge for military contractors who provide the Dept. of Defense with electronic and electrical equipment and components.

Should you need a copy of the MIL-E-17555, Revision H or Revision G, they are available from Document Center Inc.   You can also get just the cancellation notice if you need it for your records.  Because the document is canceled, you’ll need to contact Document Center Inc. directly or use our website, www.document-center.com, to get a quote.  We can be reached at 650-591-7600 (phone), 650-591-7617 (fax) or info@document-center.com (email).

New JEDEC JESD22-A110D Released

JESD-22-A110 Revision D, Highly Accelerated Temperature and Humidity Stress Test (HAST),  has just been released in November.  It is one in a series of specialized tests for solid state devices maintained by the JEDEC Solid State Technology Association.

The purpose of this test method is to evaluate the reliability of nonhermetic packaged solid state devices in humid environments. It employs severe conditions of temperature, humidity, and bias that accelerate the penetration of moisture through the external protective material (encapsulant or seal) or along the interface between the external protective material and the metallic conductors which pass through it.

The change made to the new  JESD22-A110 D, compared to its predecessor, JESD22-A110 C (January 2009) is the addition of  Note 1 and Note 2 in Clause 4.5.

The change to the JESD22-A110 C compared to the JESD22-A110 B, was the addition of a note in Clause 4.4.

Copies of this standard may be purchased from Document Center Inc. at it’s website (www.document-center.com) or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Document Center Inc. carries all the JEDEC standards under license agreement with the association.

Just Released – the New BS EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use. General requirements

The new 2010 Edition of BS EN 61010 Part 1 was just published this month (November 2010).  The new document replaces the previous 2001 Edition for this item.  It is in stock and available for purchase from Document Center Inc.  on our website www.document-center.com.

This revised edition provides a presumption of conformity with the Low Voltage Directive (LVD) and is also essential for compliance with Health and Safety at Work etc Act 1974 in the United Kingdom.

With presumption of conformity with the LVD 2006/95/, BS EN 61010-1 will enable manufacturers to fit CE marking in respect to the safety requirements contained within the LVD and the corresponding national laws.

BS EN 61010-1 also covers a large number of products that are outside the scope of the LVD [50-1000 V], but are covered by either the General Product Safety Directive or the Health and Safety at Work etc. Act: as such, compliance with BS EN 61010-1 is an indicator of compliance with good engineering practice.

This standard aims to ensure the safety of anyone that uses this type of electrical equipment for measurement, control, and laboratory use.

Who is this standard for?

BS EN 61010 Part 1 is intended for use by anyone in the industrial, scientific and medical (ISM) industry who sells or manufactures or supplies measurement, control and laboratory equipment or related components and assemblies.

BS EN 61010-1 describes the general safety requirements for electrical equipment used in laboratories. It provides the general requirements and identifies the risks users and operator could face, and the manufacturer’s design requirements and tests needed to reduce these risks.

This part of BSEN61010 specifies the general safety requirements that professional and non-professional operators should follow when using electrical equipment in industrial processes, laboratories and educational settings, and includes:

  • Electrical test and measurement equipment
    This is equipment which by electrical means tests, measures, indicates or records one or more electrical or physical quantities, also non-measuring equipment such as signal generators, measurement standards, voltage sources, transducers, transmitters, etc.

This includes bench-top power supplies intended to aid a testing or measuring operation on another piece of equipment. Power supplies intended to power equipment are within the scope of the BS EN 61558 series.

  • Electrical industrial process-control equipment
    This is equipment which controls one or more output quantities to specific values, with each value determined by manual setting, by local or remote programming, or by one or more input variables
  • Electrical laboratory equipment
    This is equipment which measures, indicates, monitors or analyses substances, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment

This equipment may also be used in areas other than laboratories, for example self-test IVD equipment may be used in the home and inspection equipment to be used to check people or materials during transportation.

What’s been changed for the new edition?

Significant changes to BS EN 61010-1 include:

BS EN 61010-1 applies to the equipment and their accessories wherever they are used, not just for professional use as previously. There is also clarification that equipment used to check people or materials during transportation is within scope.

Foreseeable misuse and ergonomic aspects have been included and a new clause has been added to address risk assessment for hazards not covered in the standard.

A further major change is the removal of test and measurement circuits to a new BS EN 61010-2-030. Any equipment containing these circuits will have to comply with this Part 2 as well as Part 1.

Electrical requirements have been added for solid insulation and thin-film insulation. Insulation requirements for mains circuits of overvoltage category II up to 300 V, and for secondary circuits are also covered.

It now contains additional requirements for protection against mechanical hazards and environments not covered by the standard. A section on dealing with risk assessment is also included.

  • Surface temperature limits have been modified to conform to the limits of EN 563
  • Radiation requirements have been modified, and take into account a distinction between intended emission and unintended emission.
  • Requirements for reasonably foreseeable misuse and ergonomic aspects.
  • Methods of reducing the pollution degree of a microenvironment.
  • Requirements for the qualification of coatings for protection against pollution
  • Explanation of how to determine the working voltage of a mains circuit.

Contents of BS EN 61010-1 contain:

  • Scope and object
  • Environmental conditions
  • Normal environmental conditions
  • Extended environmental conditions
  • Normative references
  • Terms and definitions
  • Equipment and states of equipment
  • Parts and accessories
  • Quantities
  • Tests
  • Safety terms
  • Insulation
  • Tests
  • Sequence of tests
  • Reference test conditions
  • State of equipment
  • Testing in single fault condition
  • Application of fault conditions
  • Duration of tests
  • Conformity after application of fault conditions
  • Marking and documentation
  • Marking
  • Identification
  • Mains supply
  • Fuses
  • Terminals, connections and operating devices
  • Switches and circuit-breakers
  • Equipment protected by double insulation or reinforced insulation
  • Field-wiring terminal boxes
  • Warning markings
  • Durability of markings
  • Documentation
  • Equipment ratings
  • Equipment installation
  • Equipment operation
  • Equipment maintenance and service
  • Integration into systems or effects resulting from special conditions
  • Protection against electric shock
  • Requirements
  • Exceptions
  • Determination of accessible parts
  • Examination
  • Openings above parts that are hazardous live
  • Openings for pre-set controls
  • Limit values for accessible parts
  • Levels in normal condition
  • Levels in single fault condition
  • Primary means of protection
  • Enclosures and protective barriers
  • Basic insulation
  • Impedance
  • Additional means of protection in case of single fault conditions
  • Protective bonding
  • Supplementary insulation and reinforced insulation
  • Protective impedance
  • Automatic disconnection of the supply
  • Current- or voltage-limiting device
  • Connections to external circuits
  • Terminals for external circuits
  • Circuits with terminals which are hazardous live
  • Terminals for stranded conductors
  • Insulation requirements
  • The nature of insulation
  • Insulation for mains circuits of overvoltage category ii with a nominal supply voltage up to 300 V
  • Insulation for secondary circuits derived from mains circuits of overvoltage category ii up to 300 V
  • Procedure for voltage tests
  • Humidity preconditioning
  • Test procedures
  • Constructional requirements for protection against electric shock
  • Insulating materials
  • Colour coding
  • Connection to the mains supply source and connections between parts of equipment
  • Mains supply cords
  • Fitting of non-detachable mains supply cords
  • Plugs and connectors
  • Disconnection from supply source
  • Requirements according to type of equipment
  • Disconnecting devices
  • Protection against mechanical hazards
  • Sharp edges
  • Moving parts
  • Risk assessment for mechanical hazards to body parts
  • Limitation of force and pressure
  • Gap limitations between moving parts
  • Stability
  • Provisions for lifting and carrying
  • Handles and grips
  • Lifting devices and supporting parts
  • Wall mounting
  • Expelled parts
  • Resistance to mechanical stresses
  • Enclosure rigidity tests
  • Static test
  • Impact test
  • Drop test
  • Equipment other than hand-held equipment and direct plug-in equipment
  • Hand-held equipment and direct plug-in equipment
  • Protection against the spread of fire
  • Eliminating or reducing the sources of ignition within the equipment
  • Containment of fire within the equipment, should it occur
  • Constructional requirements
  • Limited-energy circuit
  • Requirements for equipment containing or using flammable liquids
  • Overcurrent protection
  • Permanently connected equipment
  • Other equipment
  • Equipment temperature limits and resistance to heat
  • Colour coding
  • Connection to the mains supply source and connections between parts of equipment
  • Mains supply cords
  • Fitting of non-detachable mains supply cords
  • Plugs and connectors
  • Disconnection from supply source
  • Requirements according to type of equipment
  • Disconnecting devices
  • Protection against mechanical hazards
  • Risk assessment for mechanical hazards to body parts
  • Limitation of force and pressure
  • Gap limitations between moving parts
  • Stability
  • Provisions for lifting and carrying
  • Enclosure rigidity tests
  • Equipment other than hand-held equipment and direct plug-in
  • Hand-held equipment and direct plug-in equipment
  • Protection against the spread of fire
  • Eliminating or reducing the sources of ignition within the equipmen
  • Containment of fire within the equipment, should it occur
  • Constructional requirements
  • Limited-energy circuit
  • Requirements for equipment containing or using flammable liquids
  • Overcurrent protection
  • Permanently connected equipment
  • Equipment temperature limits and resistance to heat
  • Surface temperature limits for protection against burns
  • Temperatures of windings
  • Temperature measurement of heating equipment
  • Equipment intended for installation in a cabinet or a wall
  • Resistance to heat
  • Integrity of clearances and creepage distances
  • Non-metallic enclosures
  • Insulating material
  • Protection against radiation, including laser sources, and against sonic and ultrasonic pressure
  • Protection against liberated gases and substances, explosion and implosion
  • Components and subassemblies
  • Protection by interlocks
  • Hazards resulting from application
  • Reasonably foreseeable misuse
  • Ergonomic aspects
  • Risk assessment
  • Measuring circuits for touch current
  • Standard test fingers
  • Measurement of clearances and creepage distances
  • Parts between which insulation requirements are specified
  • Guideline for reduction of pollution degrees
  • Routine tests
  • Leakage and rupture from fluids under pressure
  • Qualification of conformal coatings for protection against pollution
  • Line-to-neutral voltages for common mains supply systems
  • Risk assessment
  • Index of defined terms
  • Bibliography
  • Measurements through openings in enclosures
  • Maximum duration of short-term accessible voltages in single fault condition
  • Capacitance level versus voltage in normal condition and single fault condition
  • Acceptable arrangement of protective means against electric shock
  • Examples of binding screw assemblies
  • Distance between conductors on an interface between two layers
  • Distance between adjacent conductors along an interface of two inner layers
  • Distance between adjacent conductors located between the same two layers
  • Detachable mains supply cords and connections
  • Impact test using a sphere
  • Flow chart to explain the requirements for protection
  • Against the spread of fire
  • Baffle
  • Area of the bottom of an enclosure to be constructed as specified in ball-pressure test apparatus
  • Flow chart for conformity options
  • Measuring circuit for a.c. with frequencies up to 1 MHz and for d.c.
  • Measuring circuits for sinusoidal a.c. with frequencies up to 100 Hz and
    for d.c
  • Current measuring circuit for electrical burns
  • Current measuring circuit for wet contact
  • Rigid test finger
  • Jointed test finger
  • Examples of methods of measuring clearances and creepage distances
  • Protection between hazardous live circuits and accessible parts
    Protection between hazardous live circuits and circuits which
  • Accessible external terminals
  • Protection between a hazardous live internal circuit and
  • An accessible part which is not bonded to other accessible parts
  • Protection between a hazardous live primary circuit and
  • Protection of external accessible terminals of two hazardous live circuits
  • Conformity verification process
  • Test sequence and conformity
  • Iterative process of risk assessment and risk reduction
  • Risk reduction
  • Distance between conductors on an interface between two layers
  • Distance between adjacent conductors along an interface of an inner layer
  • Distance between adjacent conductors located between the same two layers
  • Example of recurring peak voltage
  • Symbols
  • Tightening torque for binding screw assemblies
  • Multiplication factors for clearances of equipment rated for operation at altitudes up to 5 000 m
  • Clearances and creepage distances for mains circuits of overvoltage category II up to 300 V
  • Test voltages for solid insulation in mains circuits of overvoltage category II up to 300 V
  • Clearances and test voltages for secondary circuits derived from MAINS
  • Circuits of overvoltage category II up to 300 V
  • Creepage distances for secondary circuits
  • Minimum values for distance or thickness
  • Distances between terminals and foil
  • Correction factors according to test site altitude for test voltages for clearances
  • Values for physical tests on cord anchorages